Update on Burn Management Therapy

Back by popular demand, after his presentation with our conference last year Dr. Tompkins is sponsored with the assistance of Paradigm Health Corporation today. Dr. Ronald Tompkins has a medical degree from Tulane University and also a degree in chemical engineering from MIT. He is a professor of surgery at Harvard Medical School also on staff at Massachusetts General Hospital in Boston, and he is a professor of surgery at Harvard Medical School as well.

He is the national chairman for the Advisory Committee for Trauma Care Outcomes and financing for Paradigm Health Corporation in California. He is a member of the American College of Surgeons, the Committee on Trauma and also the Chairman of the National Trauma Registry Committee. He is President of the American Burn Association as well, Chief of Staff and Director of Research for Shriner’s Hospital for Children and a member of numerous professional societies as well as involved with numerous research projects for burns and trauma and finally has published extensively. He will be speaking with us today regarding an update on burn injury management, so if you would please join me, I would like to welcome Dr. Tompkins.

Well, for the next few minutes, what I have selected have been various vignettes with respect to the field of burns, to try to catch you up on some of the clinical aspects, as well as some of the organizational and delivery aspects of burn injuries.

I will briefly just talk initially about epidemiology, and I wanted to just sort of catch you up a little bit on modern management and I will try to warn you if there are any gory slides.

There has also been considerable advancement in terms of the organization and delivery of burn care and also some health services research, and I will hopefully have time to touch on some of those aspects.

Just briefly, with respect to epidemiology, injury is a very important aspect of health care in terms of morbidity and mortality. Under the age of 44, it is the most common cause of death in the United States, and it leads to a tremendous amount of mortality and morbidity.

Burns is a relatively small subset of injury. It ranks fourth, after injuries related to motor vehicle crashes, falls and poisonings, in terms of unintentional injuries, which cause death. It is very important nonetheless in many hospitals; patients with major burn injuries often become some of their most expensive patients every single year.

Fortunately, in the field, age-adjusted death rates have declined by 50 percent and it has to do with prevention as well as considerable improvements in the acute care of these patients.

How big is the problem? There is a residential fire every seventy seconds. About every two hours, someone dies from a fire, and there are approximately five thousand deaths on an annual basis. There are only sixty thousand patients hospitalized, although they account for approximately fifty to one hundred thousand dollars per case, so they are relatively expensive even though they are small in number. The fact that they are small in number is an important issue, because the expertise available to care for these patients is focused in a very small number of centers. And we’ll talk about that as we go along.

In terms of the burns field, it is very much like transplantation, in which there are 138 centers across the country that consider themselves to be burn centers and are listed by the American Burn Association as burn centers. However, there is a verification process that has currently been developed, and I’ll tell you just a little bit in which the centers have actually demonstrated that they are Centers of Excellence, and that accounts for about sixty hospitals nationwide. And we will talk about sort of the benefits of what that might entail in terms of an organized approach to the care of the patients, which results not only in efficiencies and cost effectiveness, but also expectations for high or improved outcomes.

Just so that we are on the same wavelength, this is an example of a second-degree burn. It is erythematous. It may even have blisters. These heal fine, as long as you don’t allow them to become grossly edematous or infected. This will actually heal very nicely.

However the knowledge about whether or not a wound will heal effectively requires a great deal of experience. This a deeper. This is a deep second-degree burn. You can see here there are some areas that look quite irregular. These will not heal with a satisfactory result and so it requires good judgment to figure out exactly how these should be managed. The difficulty is that if you mismanage these patients then these are the results that particularly children and adults have to deal with the rest of their lives. Not only are these cosmetically disfiguring but also can be functionally disabling.

I just wanted to show you this is a child who was treated at our institution in the 60’s. This was before we actually understood the proper way to treat burn injuries. This child was treated conservatively which is non operatively, and the result of that actually turns out in the long term to end up with scars that, as you can appreciate, you could probably do thirty or fifty operations on these hands and still have a dysfunctional result.

Well, what occurred in the late 60’s and early 70’s is an understanding that, when you have a deep -- I’m just going to take an instance involving hands, because I think most of us can appreciate the loss of function in our hands has a very profound effect on our ability to function in society. So I’m just going to take the hand as an example. And this is actually the son of a very famous surgeon from our hospital who was involved in an industrial accident and so I’ll flip through these very quickly, but you go to the operating room and you remove that damaged skin and you replace it with skin grafts.

Now, to a normal individual, this would seem like a very desperate procedure and very aggressive, but let me just show you the long-term results here at two years. What you see is a cosmetically perfectly satisfactory result that, as well, has normal function.

Now, if you extrapolate that to other burn injuries involving the remainder of the trunk and the remainder of the extremities, you can appreciate that a more aggressive surgical approach might have some value and that as been borne out over the last thirty years of experience.

I have one other comment to make and that has to do with even devastatingly injured patients have a very excellent opportunity to survive and to survive with high quality of life. So the theme here and the last few slides and the next few slides should be that, not only do patients, but payers should have a much higher level of expectation for the type and quality of the results that your patients are receiving.

This young man was riding his tricycle in a garage. It was raining outside, so the water heater exploded and he and his two cousins had a very devastating injury of greater than 90 percent of their body surface area, and here you see all three of them. They survived and Michael here, in the middle, is now beginning to play soccer and actually enjoying a normal life.

And I’ll go back to some of these issues of quality of life for these injured patients just to give you a sense of what these patients are doing fifteen and twenty years after their injuries.

So the expectations should be high. There should be an organized approach to the care of these patients. The institutions, who are suggesting that they are Centers of Excellence, should be involved in looking at their results. They should have data systems, so they can share with you exactly what their results are, and they should be participating in outcomes based management.

I’m going to hit on some of those various aspects, to let you know what resources are available within the community and that these centers should be participating in.

So what we’ve learned over the past thirty years is that this is a surgical disease and, if approached properly, you can achieve these high quality results.

I will flip through this next slide pretty quickly, but it basically is just demonstrating that you remove the damaged tissue and, once you have removed the damaged tissue, then you replace it with skin grafts. Now this is much easier said than done. In larger injuries, you are very limited with the amount of skin that can be provided. There are ways around that. I will point on one particular advance that has occurred over the last 10-15 years in terms of artificial skin, and we will touch on some aspects of that, but fundamentally is a surgical disease process.

What are some of the things of the current trends? As we briefly talked about, but I will give you some facts about it, improved mortality, infections, in terms of burn centers and hospitals, this should actually be one of the cleanest areas of the hospital. It is not like it was 20 years ago, where it was rampant with bacteria and infection. If you encounter a burn center of that nature, it should send up red flags. That is not what occurs this day.

Markedly decreased use of blood -- if you are discovering that your patients are receiving tremendous amounts of blood, unless they are devastatingly injured, that should send a red flag to you about the quality of care in that facility.

Emphasis on cosmetic and functional results -- because of our approaches that we have these days, you can actually plan and manage exactly how you approach the patient, so that you save high-quality scan for the results for face and hands and other cosmetically sensitive areas of the body. Your care provider should be aware of what has occurred in the field of burn care in terms of organization delivery. That is, development of national standards, development of national database, and they should be participants of that, and evaluations of their own outcomes, and they should be able to share those with you and be involved themselves in outcomes based management because the tools are available.

On survival, in this day in time, one percent or less of our admissions actually succumb to the disease process, so that has provided an opportunity for us, because there are children surviving massive injuries now-a-days and that has really pushed our technology much farther than we had ever anticipated. So we just looked at survival rates, just so that you would have a ballpark idea of expectations of survival at the time the patient arrives at the hospital. And this is very important for counseling.

If you made an accurate diagnosis, you know the extent of injury, what are the expectations that this individual will leave the hospital alive. This was an article published in the New England Journal of Medicine about two years ago. We looked at a large number of patients, both adults and children, in our facility, and these are typical sort of statistics you would find, 15 percent have inhalation injury; length of stay is 21 days, and that is typical for a burn center.

If you looked at our burn center, there is a mortality rate of about four percent overall, so, of all comers, about four percent will die. Very low risk patients have a 0.2 percent and that really is 80 percent of the patients.

Of the very high-risk patients, almost 90 percent of them will die, and I will show you what the risk factors are in just a moment. If you have no risk factors, you have almost a zero likelihood of dying. If you have three risk factors, you have about a 90 percent chance of dying. If you have one risk factor, you have an average risk. If you have two, you have an intermediate risk.

So, what that allowed us to do, is these are the only risk factors that turned out to be important in patients who arrived at the hospital, just to know about whether or not this patient was going to leave the hospital alive. If they were over 60, if they had larger injuries of more than 40 percent, or they had inhalation injury -- if you had none of these factors, you have almost a zero likelihood of dying. If you have one of these risk factors, you have an average likelihood about three percent. If you have two of them, you have an intermediate likelihood or about a third of a chance of dying, but certainly should be aggressively treated.

But if you have all three of these risk factors, you have a 90 percent of chance of dying during that hospitalization. Now that provides you with some fairly powerful information in terms of counseling for both that patient and their family, and it would be an educated decision on the part of not only the health care providers, but as well as the family, about what we should do about the treatment of this patient. And we have had many patients, who have had all three of these, who survived and have a very productive life. So it is not a yes/no decision, but it is an educated decision.

Moving onto the issue of blood, this is an area that over the last ten years, if you just focus here, on the packed blood cells, just a usage in our facility at the Shriner’s Hospital, 1000 units of these were used in the early ‘70s, we’re now on the order of less than 50 to 100 units of blood on an annual basis in our facility. Part of that has been driven by our own improvements in care and part of it has obviously been driven by the likelihood or possibility of transmittable diseases. But what it does tell us is that we can take perfectly care of both adults and children with very minimum use of blood from both our surgical techniques and tolerance of much lower hematocrits than we might have done in the past.

You see here that, just in terms of percentage of children in an earlier time period, versus a more recent time period, in very small injuries, almost 90 percent of our children leave the hospital never having had any blood products. We’re very proud of this. In terms of intermediate burn sizes, even up to half of their body surface area burned, almost 40 percent of those children will leave the hospital never having had a blood product. We’re very pleased about that, and that should be one of the characteristics that you find whenever you are managing or evaluating the care of patients in a burn center.

It is not the filthy facility that it used to be. The burn unit should not be a harbor of very terrible organisms and also should not be rampant with invasive wound infections. I have taken this information from [a major medical center], from a friend of mine…who runs a really outstanding facility there at the University of Washington, and he was just looking at positive cultures per patient over a reasonable timeframe.

You see here, in the ‘80s, there were a very high number of cultures per patient in that time period, and you see that there has been a very dramatic decline in that, and this is really reflective of the surgical orientation of the disease process these days. The devitalized tissue, which was such a wonderful environment for the growth of organisms, is now in the bucket and what you have is a clean wound, which has normal skin placed on it.

Just looking at infections, by ICU, from his facility, you see here that, in the coronary care unit, over that same time period, there is a fair infection rate, although it is relatively low, and it is really very similar to that what you would see in a burn center and much lower than you would see in a more generalized ICU involved in trauma. So it is not going to be free of bacteria, but it certainly is going to be very consistent with a general ICU environment.

These are rates per 1000 patient days, in terms of UTI’s, pneumonias, invasive or non-invasive infections and blood stream infections. This is from Shriner’s Hospital, and these is really for the CDC, has set the benchmark, with respect to what are the rates that you should see on this basis. And you see it is quite low for small injuries, and it does increase as the size of the injury increases particularly blood stream infections. These are overall quite low rates, and that should be an expectation.

Twenty years ago, we were all concerned about gram-negative bacteria. In the 70s and early 80s, pseudomonades, enterobacter, Klebsiella, all of those were terrible organisms. But as you can see toward the 90s, the bacteria we find in our units are really gram-positive in nature. A few fungal infections and a few gram-negative infections, but by far, gram-positive organisms are what you find in the unit. If you see something other than that, you should be concerned.

This is just an example of an awful invasive burn wound infection which we only see when they are referred to us on a late basis. But that should be a warning sign to you, if you are evaluating or case managing a patient and you find such. That is really the sign of a lack of organization, and also an ignorance with respect to what is the current management for these injuries, and should tell you something.

I want to just talk briefly here. I am back to the issue of hands, because it is so important. It’s cosmetically and functionally an important part of your body. But just to give you an idea, what should you expect when you see a patient who has a devastating injury? Let’s say like this. Be it industrial or house fire related, this is clearly a very deep burn injury. This is what we are trying to avoid remember. That occurs, and this is what we are trying to achieve, and we talked briefly about how to do that.

Well you evaluate, initially, the overall patient condition, and you evaluate peripheral profusion, depth of injury and other aspects of trauma. All of that requires considerable judgment. Now, surgically, if they are very superficial injuries, you can just do hand therapy and topical antibiotics, but it takes an educated eye to understand that.

For the deep injuries I showed you briefly, you do hand therapy and do sequential excision, that operative approach that I showed you briefly. And for these fourth degree injuries, not only do you do hand therapy but you do excisional therapy, fixation with various techniques and may even need flaps.

Hand therapy is pretty straightforward. It is elevation to reduce edema. It is progressive active and passive therapy, and splinting in a particular position so you maintain function.

So we looked at, we were curious about this. We have aggressively treated these sort of injuries for almost 30 years. So what we did in our adult population, we looked at our last thousand or so injuries, and we did the same last thousand or so injuries for hands in our children’s population.

We developed functional categories, and these are outcomes, that a functional A means normal or near-normal movement, no amputations, and you don’t need devices. B is there are some abnormal movements. They may or may not have amputation, but they can perform activities of daily living independently without devices. C is an abnormal movement, and they do require devices. So A is pretty normal. B is satisfactory and functional. C is a bad result. This is in the adults, the last 1,047. And these are the outcomes that you expect.

In terms of the A Category, which is normal function, Category 1, which is the superficial injury, almost all of those are expected to have a perfect result. Even when all the skin down to and through fat, almost involving tendons, those almost 90 percent should have normal function. Looking at this on the basis of 1,000 adults and 1,000 children, your expectation should be 90 percent of those patients should have completely normal function. In terms of Category 3, where the injury is very deep, even 20 percent of those patients could even have perfectly normal function if treated properly.

And clearly, if you have a much higher rate of poor results but even in the case of very deep injuries, you have reasonable expectations at a good quality result should occur.

Just to emphasize briefly, these Category 1 injuries in children, 97 percent should have a perfectly functional result. In a Category 2, remember this is what we are trying to avoid, the issue is that we have operatively treated this. Sixty percent will require an operation over the next five years, that will be a single operation.

Normal results should be seen in 85 percent of those cases. These are cases where there has clearly been a very devastating injury to occur. And these are those very difficult cases where bones and joints have been involved, but even in that case, 71 percent of those patients were able to perform activities of daily living either with or without devices. So the expectations should be quite high.

So let me shift gears here to that issue I alluded to a little bit earlier. What if you run out of grafting materials? What alternatives are there? I just want to briefly mention what the state of art, in terms of skin replacement materials, because, number one, some of them are actually extremely effective. In terms of patient care, it helps you close the wound earlier. The difficulty is they are also incredibly expensive.

A product like Integra, which I am going to talk about in a little more detail, is $1,000 for a 4x8 inch piece, and you can very easily spend $30,000 or $40,000 on just materials in order to provide closure in some patients with larger injuries. But it has had some very dramatic results in terms of cosmetics and function, a little bit of which I will share with you.

It received FDA approval in March of 1996. It has required an extensive physician education program in order to educate surgeons on the proper management techniques with this material, which, by itself, has been a real learning experience for me to be involved in that process. Alloderm is another approach, which I am not going to talk about. Dermograph, these are both materials that are commercially available, but are not permanent materials.

Well the technique really has to do, as we talked about, is removing the devitalized tissue in a timely fashion, having a well-prepared wound bed and then placement of the skin replacement material and fixing it as you would a typical graft. And I tell you, step one and step two is the hard part to teach some of the doctors to do properly. And then after about two to three weeks or longer, you remove a Silastic layer, and it leaves a new dermal base, which can then have a very thin epidermal graft placed upon it, so that you replace epidermis, and you have a new dermis. And this new dermis actually reorganizes itself in a fashion very comparable to our own normal skin.

So, what the Integra really does is, it provides a scaffolding, and post elements migrate into the scaffold, and a three-dimensional anatomy is then recreated out of host materials. Normally dermis doesn’t regenerate, so this scaffolding was required so that the dermis can be recreated. That is the essence of its success.

I want to give you one illustration because it is one of the earlier ones, after FDA approval, it doesn’t come from our center where my predecessor was actually one of the inventors, together with one of the professors and mechanical engineer at MIT, of that particular product. This…just illustrates the power of the use of this sort of material.

This was about a 45-year-old fellow who was involved in an explosion. Sixty-five percent of his body surface area has a very deep burn injury. Here you can see on the forearm and the hand and involves 65 percent. Very few areas of his body are spared. Typically a patient like this would be in the hospital about a day per percent burned.

He had a bit of an inhalation injury, so you would normally expect him to be in the hospital maybe 70 days. He came from Alaska... Here you can see his back, and it is pretty obvious which areas are deeply burned. All this tissue needs to be removed and replaced with grafts.

You see there are some areas of sparing, where you can get some donor site material. This was, for example, on the arm, surgically approached. The devitalized tissue removed. Here Integra has been grafted in place. You can see the Silastic area. You can see the underlying tissues here, because it is perfectly transparent.

Teaching physicians how to read and evaluate the progress in wound healing, when you can actually see the underlying structures, has been a real challenge. It is not something any of us have been used to. This is the leg that has been engrafted with Integra. The approach to this patient was, “Let’s put our very best graft material on the hands because it is so important.”

So we took skin, full-thickness skin grafts, placed them on the hands, and everywhere else this individual was burned, received Integra. Here is just sort of a way of holding it in place. You use Surgifix, and the day after the surgery, this is the dressing, and the patient can actually be up and around in the hospital.

See, this is what it looks like at two to three weeks, with the Silastic having been removed. This is a very unusual-looking wound bed. There is no granulation tissue or anything. If you looked at it, it looks like a rather inert surface, which looks a little bit like cardboard, and to a surgeon that was very…surgeons are very used to putting skin grafts on granulation tissue.

Now granulation tissue is a combination of fibroblasts and endothelial cells, with no three-dimensional structure and is guaranteed, in the long run, to develop scar. So the granulation tissue is a very bad thing and will, 100 percent of the time develop scar. But unfortunately, surgeons have learned that granulation tissue accepts grafts almost 100 percent of the time and so, ultimately, you can develop wound closure.
We are going to a new generation. Now the new generation is the development, the reconstruction of a normal dermis, which will not scar. It will have normal cosmesis and function. It is the dermis of skin that actually gives you cosmesis and function, and this is reconstruction of a normal dermis. So early on, the surgeons actually take a surgical knife and scrape this off and make it bleed, because you know that a bleeding surface accepts grafts much better. It has been an incredible learning process just to see the surgeon’s behavior to work.

This is a very thin epidermal graft. Epidermal cells migrate off of these very thin grafts and fill in the intestacies here to develop a normal surface. This was just at a dressing change a few days later. It can look pretty gross. This is at two weeks afterwards. This particular surface here, it was removed down to the level of fat.

This is two weeks later, and the fellow is actually getting ready to go back to Alaska. He was discharged on the 32nd post-hospital day, he was there about a month, is less than half of what it would be expected, and the quality of the result here is extraordinary.

Here both the lower extremities were extensively covered with Integra. There is a learning curve here, because there are some irregularities here. The secondary grafting, that thin epidermal graft we talked about, was a little too thick here, and we’ve all had to learn. Here it was thinner, and it has a very nice smooth cosmetic result. Wounds, typically the first six- to twelve-months, are erythematous and angry-looking, but this is really, extraordinarily nice, and, at one year, this will be this color and a nice, smooth surface. And this is the back at the time of discharge.

There are many advantages to this. His only donor sites, and you can’t see here very well, I didn’t bring all the slides just for the sake of time, but the donor sites are very thin. There is very little donor site morbidity related to this. They heal much more quickly, and certainly the quality of the graft at surface is really extraordinary.

The first patient was seen in 1979. Even in the early phases of the FDA studies at our hospital, we used it about 200 times. Since its FDA approval, we’ve used it another 200 times. We’ve had a pretty considerable experience with it. We’ve looked at our first patients, which now gives us an opportunity of looking at it ten to 15 years, to almost 20 years later. And during the first six months post grafting, 78 percent felt that Integra felt in function more like normal skin than their own meshed autographs.

There is far less itching in those patients who are prone to hypertrophic scarring and keloid formation. It is actually a treatment of hypertrophic scarring and keloid formation. You can actually excise keloids in patients who form keloids and close it with Integra, and there would be no keloid formation after that. Eighty-four percent of those patients, at this long-term follow-up, felt that the cosmetic appearance was superior to that of their meshed autograph.

I guess that my point is here that we are embarking on a whole new era in the field of burn injury, where you can actually resurface these patients with an expectation of quality that is better than their own meshed autograph, and this has really been an uphill battle, getting this across certainly to the surgical community. But I think that, both patients and payers and those who are managing the care of these patients, should understand that we are entering a new era where a much higher level expectation should be held.

Just in the last 10 or 15 minutes here, to give us plenty of time for discussion, I just want to hit on a few issues that are important in terms of organization and delivery of burn care in the US. Just some comments about outcomes, cost, quality of life and long-term follow-up verification program, which I alluded to, as well as the development of databases for benchmarking on a national basis and the role that might play in the local centers.

Well, there is a pre-hospital triage of injuries to centers. As we mentioned, there are 138 self-designated centers. About half of them, or 60 of them, have gone through a formal application process, which is a program that would help you to identify centers who meet a consensus for being a burn center.

The field sat down about eight years ago and decided what are the resources that are necessary for optimal care of burn injured patients. What are the hospitals and what are the medical resources that are necessary? And this consensus document then turned into a program, at which a hospital can apply, demonstrate how they meet those resources, and there is actually an on-site verification process that indeed they do meet those criteria.

Then they can be verified as meeting those standards. We felt that it was important, from our own field to come up with our own guidelines for this process, but it is intended to serve as a resource to the community, particularly the payer community who has a very difficult time figuring out who is a burn center and who is not, and I think we have been very successful with this.

The program we have developed uses evidence-based guidelines, and part of this was supported by the Coalition of Burn Center Hospitals, as well as Paradigm Corporation. I am not going to have time to present those guidelines, but you should be aware that guidelines are available and can be obtained through the American Burn Association.

Outcomes and development outcomes-based systems of patient management are becoming available, and there is now a National Data Repository for burn injuries, which would help properly stratify and develop benchmark standards for utilization of resources such as length of stay, ICU length of stay, days on the ventilation and other surrogates for cost management.

Just to briefly describe that verification program, I described that there is this consensus document, which talks what the resources should be. One of the most important resources is an organized burn service. It is managed by a single director. The patients are on that service. There is a knowledgeable group of nurses, therapists and there are proper resources available. There is an educational component to that. There is credentialing privileging aspects to that, but there is an organized approach to the care of these patients that is easily demonstrated, and that is demonstrated by both adherence to guidelines, as well as the development of protocols. So, this systematic approach to the care of these patients is extremely important. And if you visit a program and they can’t easily demonstrate this to you, you should be very concerned.

Certainly, the major burn injured patients do arrive at the well-recognized centers. But my point is that, even if you have smaller injuries that are not of such a massive size or are not life-threatening but are very important to patients -- that is their hands, their feet, their face or considerable pieces of their anatomy, they could also be just as devastating to the patient as if it were a major injury.

So even an organized and systematic approach to the care of those patients gives you a much higher level of expectation of outcome, and those patients are just as important to be treated in a knowledgeable center as the major burn-injured patient. And those are the ones we are missing these days, and, unfortunately, neither the payer nor the patient community is aware of these resources. And I do hope that things like the Internet will help people become more aware.

And clearly there needs to be an institutional commitment. But when you approach a hospital and ask if they are a burn center and they indicate that they are, they should be able to produce a certificate from the American College of Surgeons and American Burn Association, which indicates that they are currently verified as indeed being a burn center.

There are a lot of other aspects; qualified, interested, dedicated medical director, medical staff, the nursing rehab and additional burn team that is also not only qualified, well-educated and is active in their CMEs or CEU activities. There is a very extensive quality assurance program in place. This onsite verification process is not like the joint commission. You actually have two active practicing surgeons in the field of burns who actually look over the medical records of selected groups of patients.

These site visitors know just as much about the care of these type patients as the medical director in that burn center and so there is a very in-depth review and discussion about the outcomes in that program for a medical record review.

Each of these centers is required to have a registry program, in which all of their patients are entered. They are over 250 demographic and other clinically-related data elements that are required, as well as very extensive evaluation of outcomes, in terms of complications and audits and resource utilization, and these are easily provided, not only to the site visitor, but, if culturally, we evolve, that kind of information could also be shared in some fashion with the broader community. And, in clear, there needs to be a process in place to ensure that the program is actually carefully looking at their outcomes and modifying their practices, based on an evaluation of their own outcomes.

I wanted to switch the subject a little bit, and I hope, in the question and answer session, we might get back to that organization in terms of databases and verification and other sorts of aspects…but a question in our mind in terms of outcome was, are we really creating a group of patients who are going to be devastatingly injured for the remainder of their lives from an emotional or physical perspective? And that was a great concern to us, because almost all children who come to our hospitals, even with devastating injuries leave, and we see them, and some of those children have 30 or 40 operations during the course of their lifetime.

I was a keynote speaker at the British Burn Association about five or six years ago, during one of the re-elections of the Premier. And in the BBC and the British Press, there was quite a bit of discussion with respect to treating burn-injured patients and having to send them to America to receive proper treatment. The National Health System in Great Britain doesn’t see any benefit to treating children with large injuries. They would just allow them to die with dignity. I certainly don’t hold that view, so I was selected as a speaker on the other side.

But what it did was cause me to come back and look at our children and let’s see what happens to them. This was published in JAMA in January. This issue is “Survival Versus Quality of Life,” and we recognize that there is a potential for very poor outcome. We recognize that, and we are trying to manage that, to minimize this likelihood of a poor outcome. And we recognize there is a vast commitment of healthcare resources.

Part of my job as chief of staff at the Shriner’s Hospital, which is a totally free system. We don’t have an Accounts Receivable. There is no billing department. So the Shriner’s spend over $500 million a year for orthopedics and burns, and I certainly appreciate the commitment of resources.

But we also have to change our focus from this acute survival to long-term quality of life issues and use this information to change our behavior in terms of acutely managing these children. If you look in the literature, it is really pathetic. There are limited studies. They are short-term. They say that actually quality of life gets better as the burn injury gets larger. That’s stupid. There was a point here, that was known from the literature, that we have discovered is extremely important and is actually the major determinant of the quality of life after burn injury, and it has to do with the function of the family. It has to do with social support. It really doesn’t have that much to do, provided you are doing a high quality level of care acutely in the hospital and provided that that is a high quality care.

So 147 patients, who were admitted over that time period -- we stopped in 1992 because we wanted long-term results -- 80 patients discharged alive. We used private detectives and all sorts of things. We found all of them. Only four had died since discharge, and that is five percent. There was a big concern that all these children were going away and committing suicide and living as hermits. Well, there were four percent. There was one possibly that committed suicide alone that is highly controversial. Some died of other disease processes, and one was in a drive-by shooting. They were mostly males, with burn injuries, large burn injuries, terrible inhalation injuries.

They stayed an average of six months in the hospital, 4-6 months. So these are big spenders in the environment. They are certainly the high end. What were they doing an average of 15 years? This is follow-up is 15 years, on average, so this is very long-term follow-up. A third of them were full-time students. A third of them were otherwise gainfully employed. Sixteen percent were unemployed and living independently. There were a few of them that had chemical or alcohol dependency. Some were homemakers and one actually had some family assisted living and one was in prison.

Now frankly, that is not too bad for this sort of patient population that we are dealing with. Clearly almost 80 percent were students, gainfully employed or living fairly independently at home.

What we did is we use SF36 evaluations. We are trying to see what their quality of life might be, and we matched that with age-match controls. What it turns out is that children who survive these massive burn injuries have a quality of life as determined by SF36, which is comparable to their age-match general population. There were no areas that SF36 evaluated that demonstrated any differences in this patient population from that group; despite the retrospective nature of this is a complete cohort, and this actually challenges conventional wisdom that aggressive treatment of these massive injuries in children is futile.

So we have a very upbeat positive view, and we feel that you should provide the very highest quality of medical care, with the expectation that both these children and adults are going to return to work and be a very productive, contributing member of our society. And you shouldn’t make any predetermined decisions about what their quality of life is going to be. We expected that, because we see these children and have continued to see them for many years, as well as adults, and so we were not surprised at this.

Our next level of evaluation is really going to focus on what are the early signs of a person who is at risk of an adverse outcome. In those instances then, we can provide the social supports and early discharge in order to improve and to avoid that likelihood of a poor outcome. And it really has to do in subsequent studies that I didn’t have time to show you, it has to do with the level of functioning in a family. How well integrated are they? Do they follow up with you in the office, in the clinic, and are they trying to implement the measures that you are prescribing for them?

I mentioned that fact that we were using SF36. That is not a really great outcomes measure, because there are many aspects in burns that are very different than what the SF Short Form 36 was established to measure. Although it was the most broadly-based outcomes measure quality of life tool that we had available. So, as a field, what we’ve decided to do are to develop our own quality of life measurements tools, and I don’t have time to go into it in any detail, but I just want to give you an idea of what are the domains that are important.

One thing we did is we stole a lot of our instruments from the pediatric orthopedic surgeons of North America, because some of the physical aspects of burn injury are similar to what you see in congenital and acquired diseases in pediatric orthopedics. Certainly evaluating upper extremity function is important, physical function and sports, as well as transfer and mobility. However there are some odd things that drive patients nuts after they had have a burn injury. One is pain. One is itching. A big area is appearance.

There are many aspects of emotional health that are much different than in the average population -- social function, because of their cosmesis and some of the disabilities that they have from joint movement become important. Neck and shoulder function is extremely important. It is very hard to brush your teeth, comb your hair. School re-entry is an issue -- satisfaction. These have been domains that we found as being far more important.

But what we have done is we’ve taken, just initially, in this outcomes development tool, we’ve looked at children who are school-age, and we have developed an outcomes measurement tool here, jointly sponsored by the American Burn Association and Shriner’s, and have had a very successful tool that is a specific pediatric burns outcomes instrument that is highly valid with extremely good statistics and reliability, and this is currently available, and we’re beginning to support the development of a national repository of this information. So that, as a payer or case manager, I would hope in the near future that this kind of information would be specifically available from the institution that is treating the patient, and their participation in this program should be seen as a very positive aspect of the organization of that service in that hospital. So this is available for ages five through 18. At 11 through 18, the patient can actually take the test. From five to 18, the parent can answer the test.

It is interesting to see that, when the patient is an adolescent and the parent, when you compare the two, you find that there are some areas that they agree and there are some areas they don’t evaluate, as you might expect from adolescent and parent interaction. But this has been quite interesting. The tools are available, and the national benchmarking is under way in terms of this development.

We are kind of naïve in this outcomes measurement tools business. We wanted to have a tool for under the age of five. It turns out that there is very little in the way of good tools in the preschool group. However, we weren’t aware of that, and we embarked on it anyway.

I am very pleased to say that we actually do have a valid tool that we’re just reviewing the statistics this next month that has turned out to be extremely reliable, and our third project which we are embarking on is the tool for the young adult which would really be 19 through 30, approximately, and it’s as these children then go into society, they leave home, they get married, they go to college, they get a job, those sort of transitional activities, to evaluate how the burn injury has impacted their ability to do that so that is our last field of endeavor in terms of development of our outcomes tool, that is our current state of the art.

Well, I have been wanting to leave plenty of time here for questions. These were just some selected topics in the field of burn injury. I just wanted to touch bases with you with respect to the epidemiology. It’s a very small field -- requires a very high degree of expertise and so they tend to be focused in centers. There is an advantage to having your patients in those centers. There are many ways that you can evaluate whether the center is well-organized.

There is the verification program. There is the presence of registry. There is outcomes information that you can request from them, that they should have readily available. They should have protocols and guidelines. They should be participating in outcomes management programs. So there are many things available, and I wanted to touch on some of the clinical aspects, just so you get an idea of how this disease is managed in terms of surgical process and what sort of tools are on the horizon or are becoming available, such as this tool of artificial skin. So we’ve touched on a number of different areas. Hopefully you might have some questions. Thank you very much.

Questions for Dr. Tompkins?

Q: Hi. My name is Mary Beth Williams. I am a nurse case manager. With the artificial skin, how soon does that have to be placed if they don’t have any inhalation problems? Is that something that could be delayed or something you want to do immediately or within how much time?

Tompkins: That is a very good question. Surgeons across the country, who are trying to use this technology, don’t know this answer either. The way it is successfully used…a patient comes in the hospital. They are actually -- for the first week or so -- they are in their healthiest condition that they are going to be, although they look terrible.

Physiologically, they are in their best condition during that first week so, typically, I would say we are talking larger injuries, those who are at risk of dying. We usually give 24 to 48 hours for some physiological correction. They get tremendous permeability issues, huge fluid shifts during the first 48 hours, and it is difficult to manage that kind of patient in the operating room. However, by about 48 hours and during the remainder of that first week, they actually should have gone back to the operating room and had all the permanently damaged tissue removed. Then the question is how do you close those wounds?

In the case where you have the patient’s own skin and can do meshed autographs, then that is sort of the typical approach. However, that is also the perfect time to put Integra on. Integra needs to go onto a wound bed that has all the dead tissue, devitalized tissue removed and very low or no colonization of bacteria, and then the Integra provides wound closure, just as a meshed autograph or a sheet autograph provides.

So all of this should be done certainly within the first week, probably within the first four or five days after the patients come to the hospital. If you wait for two weeks or three weeks, you inevitably have granulation tissue. Granulation tissue is a combination of fibroblasts, endothelial cells and bacteria. If you look at it very carefully, the very top layer of granulation tissue is a solid layer of bacteria. Certainly an artificial skin is not going to fair well in that kind of environment. So granulation tissue begins to be fairly prominent during the second week after the injury, and you should have already closed the wound properly before that, if you would like to have a high quality result without scarring.

Q: Doctor, I am Daniel Graph. I represent one of the payer’s here today.  I’ve caught two things from what you’ve said. One is that the care of burns today is more appropriately more surgical than historically, and one can easily see that in the case of the hand where there is so much tendon involvement. Is that the case for other portions of the body? That is part one. Part two -- you’ve suggested that hospital stays may be lowered and that the use of blood products may be lowered as well. Are those the primary contributors to what I believe you’re implying is now a more efficient method of handling burn cases? And if there are other sources, would you outline those as well.

Tompkins: The first question has to do with -- we use the illustration with respect to hands. I’m just using that as an illustration. That is true elsewhere. The only area of controversy really has to do with the face, which is kind of interesting. Deep injuries of the face, very controversial -- how you deal with that. It is not life threatening, and it is fraught with disaster. So, typically, we have been very delayed in our approach to the face, and our face is clearly about the most important aspect of our body because it is what we interface the world with.

But it has turned out that the really high quality surgeons in the field have actually taken an aggressive approach again with the face, particularly with the use of Integra, and they are startling results, if managed properly. But we don’t get quite have the principles involved so that we can routinely expect an extremely high quality result in the face, but I have to tell you over the last year or so, particularly, as I have traveled internationally, I think we are on the verge of that.

So I am really pleased and proud about the field, because I think that, and something that is that sort of my shtick right now is to raise the level of expectations on everybody’s behalf about the result should be, and I would like to see ten years from now, that expectations are extremely high and these patients not only are functionally, but also cosmetically, virtually normal. The best way to do that is to treat it properly in the beginning. If you missed the boat in the beginning, you can do 30 or 40 operations later on, and you will never had it fixed. But if you do it right the first time, then you do touch-up operations to make your result perfect. But you already are dealing with an excellent result. So in this second half of your question, can you remind me….

Q: The sources of savings that you’ve noted, some of its perhaps a 50 percent reduction in the length of stay, another is the lower use of blood products, are those consistent sources of greater cost efficiency?

Tompkins: I’m frustrated with the fee. Just take one for instance. Because this issue of Integra, I can easily end up with a $30,000 or $40,000 invoice now to deal with in my hospital. Those invoices are not typically passed through because, certainly, in Massachusetts, we’re case-rate based stay. Eighty-five percent of our cases are case-rate.

So my argument is with the hospital administration to pay this invoice and try to demonstrate to them how they are going to provide the discharge in a more timely fashion, and they have cost offsets from other resources. I was really after the company to help fund some studies along this line, and unfortunately we’re pretty much in a sort of a bind. A good quality study has not been done there. But, what I can tell you is that, certainly, it is our distinct impression and, indeed to the extent that our very fussy administration agrees with us, that the resource utilization in terms of the intensity of care of these patients in the ICU and the length of time, ventilator days, and other kinds of antibiotic and other intense resource utilization is considerably down.

In our own hospital, the burn center is the most expensive per diem area in the entire hospital, in our adult hospital. So we have made the argument. I am frustrated in that the industry hasn’t really done a cost-effectiveness…supported a cost-effectiveness study. But at least as a clinician, the entire group of us is very much convinced.

Certainly, if you look at patient outcome and the quality of the patients, part of the frustration is the way we finance healthcare, because usually, as payers, you are involved in the acute hospitalization, but then the acute rehab in the long-term is yet another issue.

In these patients, only about a third of the cost is really this acute hospitalization. A third of it accounts for the acute rehab and then you’ve got the long-term. So for example, the Workers’ Compensation field, who is on the hook for the entire care, have actually been very actively involved with us, and they are actually our best referrers, because they understand, if you get the patient to a higher level of outcome at that initial hospitalization, that the amount of money they need to set aside for the long-term is markedly diminished. So they’ve been convinced.

Q: Is there a central repository, a web site or some central source of information for the verification of competence and also of the outcomes? Is there any place we can look rather than contact each organization?

Tompkins: The best information in trauma, with some information in burns, is at the American College of Surgeons, it would be www.FACS.org.  Specifically, for the burns, would be Ameriburn. The ABA was already taken by the lawyers. So they got to it before we did, but Ameriburn.org is the description of the verification program.

Tompkins: The question had to do with does it clearly identify those centers that are verified? Now, for example, the joint commission very much wanted to provide this verification with deemed status, and the problem with that, I mean they love the process, and they find it much more in-depth than their review of the program, so they very much wanted to do that.

The problem with that is they require the results to be made public. It is quite clear that hospitals will enter into this verification program on a voluntary basis, provided that, if they fail, they are not going to be publicly humiliated. You can appreciate it in a community where there might be some competition failure and some disclosure of that failure among the communities would be rapidly discovered. So, since it is a voluntary program, there is not a public disclosure of the results. If you were to call the American College of Surgeons and ask them for a listing or ask them regarding a specific hospital, they will simply tell you that if that hospital is verified, they should easily be able to provide you with their current certificate. And they should be able to fax that to you.

The problem is, with the public disclosure, is that hospitals and administration have told us they won’t enter into the process and so it would kill the volunteer nature of the program. And I don’t know how to get around that. We’ve developed the program to the extent that we can, and personally I wanted to list. In the brochures, we list burn centers with the resources and that sort of stuff, and I wanted to indicate in there which centers were currently verified, and I ran into an incredible outpouring of angst over that. The industry is not there yet. We would like for it to, because we’ve got all the tools and all the information available and both the patients and the payor community should be aware of this. We made a big leap, but we’re not all the way there.

Q: Hi. As a rehab nurse who handles burn patients out of Boston, with you, could you comment on a little bit of the uniqueness of the ability of your community outreach because, in the Fall, I will be going to the clinical piece, where I can actually go in the burn clinic. I think that is a real important. It is very unique of the program that we have in Boston.

Tompkins: We’ve realized that…now we’ve talked about that there are very few center, there are very few hospitals that actually provide the support that is necessary, so you can aggregate the expertise in the acute hospital care, because it’s not just the doctors. It can’t just simply be a surgeon practicing medicine. This is a team approach. It is the nurses, the therapists. It is everybody. I mean even the secretary can tell you a lot of what’s going on about patients and can educate patients and family with respect to what is going on so that is the acute hospitalization.

We also realize we have a philosophy at our institution that we keep the patient until they are rock solid. We rarely will send them to another in-patient rehab facility, because we typically find the level of intensity.

Most of the rehab facilities cover many different issues and so the intense rehab therapy is not quite as intense as it would be for us so we keep them longer, and that is a philosophy and sometimes we pay a price for that, but that is just what we do. So our patients then more typically are discharged to the out-patient environment.

What we found that is that it is in our best interest and the patients’ best interests, if we spend time with those care providers in the community. Let them know exactly what typically occurs with these patients in the hospital. What are our goals, and with a better understanding what those goals need to be in the community. Then when they come back to see us, they haven’t dropped back in their care. Their care has not been compromised.

So we have aggressively gone out into the community, and we have an educational program. One of our nurse practitioners has been running this for the last four or five years. She is really interested and wonderful at it, but, on a regular basis, we bring in individuals from the community who are going to be caring for our patients and spend time in the unit and spend time on the floor and meet individuals and try to develop the resources that we need because patients are going to be discharged throughout the New England area, and we need that.

So I would like to see more centers do that. It is an aspect of our verification program. It hasn’t been something that has been as intensely reviewed. In some areas of the country, it is not as much of an issue as it was for us, but it is for many, I think. But there is a requirement in the verification program that you are very actively involved in the community, and this whole issue of continuity of care is something that is taken very seriously, because you can do all kinds of wonderful things for the patient and then discharge them from the hospital, and when they come back to see you they’re a disaster, and you can never get back to where they were when they left, and so you have to assume that as an obligation in terms of this field. I am actually very proud of the field or willing to take that obligation.