The role of nutrition in treating and healing wounds
Frustrated by a dearth of scientific research on the effects of nutrition in wound care, S. Kwon Lee, MD, FACS, initiated a study to determine what results a proprietary, concentrated protein supplement would have on wound healing in nursing homes, and he wanted to find out if a measurable difference could be seen in the healing rates of residents who were given the supplement compared with the healing rates of those who were not. “Using a protein supplement is important, but the problem has been a serious lack of science and good clinical studies demonstrating what kind of protein supplement is necessary, and what’s going to make a difference,” he says.
A board-certified general surgeon and certified wound specialist, Dr. Lee is part of Northeast Surgical Associates and practices in the Greater Cleveland area. Over the past five years, he has helped to develop the group’s wound management services into a viable and growing part of the practice, leading to the creation of Lee Warner Medical Interventions, of which he is chief medical officer. Lee Warner Medical Interventions is creating a network of physicians and nurse practitioners dedicated to the science of wound healing and delivering it to long-term care and home care.
Dr. Lee, a national speaker on wound care who served as a member of the advisory council to the National Pressure Ulcer Advisory Panel, concentrates on the commonsense approach to wound management based on science and research, not traditional or unproven methods. Dr. Lee was the principal investigator in the double-blinded, placebo-controlled, randomized multicenter trial of nursing home residents that measured the efficacy of the highly concentrated nutritional protein supplement. Dr. Lee recently discussed the study’s results and what they mean for the future of wound care with Nursing Homes/Long Term Care Management.
What are some of the misconceptions about and problems with wound care today?
Dr. Lee: I believe that the biggest problem is that very few physicians have actually learned wound care during their training or in medical school. Modern wound care is something that is not familiar to most physicians. Beyond that, the problem is that because so much of wound care has been based on tradition, there has been a serious lack of scientific data. We have physicians who depend on clinical data but don’t understand wound care, and when they try to learn wound care there’s no good clinical data—it becomes somewhat of a vicious circle.
Many of these studies are one person’s experience—one wound care expert who tried this one product on 50 patients and they all did great. Well, compared with what? And that’s what people fail to ask. What is this compared with? Why are you getting these good results? Highly trained wound care experts are going to have good results regardless of what you’re putting in their hands. As wound care continues to grow, advance, and develop, we are finally seeing more and more companies realize that we need good clinical data, more than just an anecdotal experience and more than just a case report. We need good, randomized clinical trials that are done in the real world.
What was your study’s approach toward wound care and healing?
Dr. Lee: When we decided to look at an important aspect of wound care—nutrition—we found that there were almost no randomized clinical trials in the literature. Again, it was anecdotal experience, and nobody was really comparing one product versus another, one technique versus another. What we were finding was that even though people were getting protein supplements, they weren’t getting better.
When we started investigating the different nutritional products for wound care, we found ProStat, a proprietary, concentrated protein supplement that looked to be different because it was a concentrated, hydrolyzed, fortified protein supplement. And that’s probably the key difference with this supplement versus the majority of other protein supplements. The protein is already broken down into amino acids so that the body can simply absorb and use it. We wanted to see if we could make a difference with this product in actually measuring wound care—not changing anything other than simply giving the supplement or not. Could we see a measurable difference in the healing rates?
We wanted to put it in a real-life situation, and that’s why we went into the nursing home setting. The nursing home setting is truly a difficult venue to work in because there are more and more highly acute, sick people are being discharged from the hospital directly into nursing homes. The problem is that nursing homes do not have the same resources as a hospital. We felt that if we could do the study in that setting and show a difference, that would be beneficial and of true value for a lot of people who have wounds, especially in a long-term care setting.
We also wanted to do this in a randomized, controlled fashion, so that it wasn’t me personally making sure that every single person got the supplement. We took the product and put it into the hands of the average caregiver—nursing home nurses. We wanted to see if we could demonstrate results in these people’s hands, not in any wound care expert’s hands, but rather with somebody who’s going to be using it on a regular basis and may not necessarily be a highly trained wound care expert.
How many residents participated in the study?
Dr. Lee: We ran this multicenter trial in 23 long-term care facilities in four states. A total of 89 residents had pressure ulcers—108 ulcers in an eight-week treatment period—varying from stage II to stage IV, and 71 residents completed the study. Residents were randomized to receive standard care plus the concentrated protein supplement, or standard care plus placebo—the nursing staff did not know whether they were giving the supplement or placebo. It was completed blinded to eliminate bias. We measured PUSH (Pressure Ulcer Scale for Healing) Tool scores, which look at measurements, the quality of the wound, the characteristics of the wound, and so forth. PUSH scores are quantified; therefore, we’re able to follow these wounds and track whether they improve.
The exclusion criteria were if someone had a terminal diagnosis, if they were in hospice care, anyone who had any active metabolic or GI disease that may interfere with absorption, anyone with food allergies, people on steroids or antibiotics for an infection, and anyone who had a protein-restricted diet due to renal insufficiency. Everybody else presented to the nursing home with a pressure ulcer or had developed one.
What were the study’s results?
Dr. Lee: After eight weeks of treatment, the residents who received standard care plus the concentrated protein supplement had about a 96% improvement in wound healing based on the PUSH scores. Again, the PUSH Tool provides numeric scores of parameters such as the amount of drainage, wound surface area, and tissue type (evidence of healing and granulation tissue), and then it gives a numeric value—that’s how we’re able to track these wounds.
We were still providing standard of care, and there was improvement of the wounds in both groups, so wound care is still important. We saw improved PUSH scores with the standard of care; however, with the variable being the addition of the supplement, we were able to demonstrate a 96% improvement of the PUSH scores above and beyond the control group. Pretty much everyone in the study demonstrated improvement, but it was in the nearly two times acceleration of that healing process with the proprietary, concentrated protein supplement that we saw the difference.
We did not stop any of the other protein supplements that people were getting. If the other protein supplements were really working, then residents’ wound healing would be at a fairly high level. But because there was a 96% difference, nearly twice the healing rate, that told us there are significant problems with the other protein supplements that we use. That verifies the clinical observation that even though people are getting protein supplements, they’re not getting better.
Because the concentrated protein supplement is hydrolyzed, the body does not have to go through the process of trying to break down the protein. For example, if somebody has a 2,000 calorie diet, the average normal, healthy person would spend more than 1,100 calories of that diet on digestion. You can imagine what kind of energy reserve there is for somebody who is 75 or 80 years old, just discharged from the hospital, is still very sick, and is still trying to recover from medical problems. These folks have very little energy reserve to digest their food and use the protein that we’re trying to give them.
The other problem is that most protein supplements come in a liquid form, which means residents have to drink a lot of additional fluid that they simply cannot handle. To try to eat three meals and drink three cans of supplement when you’re 85 years old is not an easy task. The concentrated supplement provides 15g of protein, which equates to almost two cans of anything else out there, but it comes in only one fluid ounce. It can be given when other medications are passed, and it’s so much easier for residents to use. That’s why I think we saw the dramatic improvement in the wounds.
Another challenge is education. This randomized study makes a big difference, because showing a randomized clinical study to a dietitian or to a physician carries a lot of weight. They realize that this is not just somebody trying something and simply saying it works. I’m hoping that more people will do these kinds of studies and research. We need to increase the level of sophistication and science because wounds are going to become even a bigger problem as the baby boomers age.
How does nutrition affect wound healing?
Dr. Lee: As you get older, you lose lean body mass. You lose protein and muscle mass and, therefore, you are more prone to infection. But you are also more prone to skin breakdown simply because there isn’t as much healthy muscle to protect the body and to provide circulation—the muscles help bring circulation into the tissue. Studies have shown that if somebody has, for instance, a low albumin level, not only is the resident at risk for not healing a wound, but he or she is at higher risk for developing a wound because protein is needed for healing. The whole process of wound healing involves the creation of new collagen and new protein, and protein stores are needed in the body to heal that wound. In many nursing home residents, especially if they’ve just come from the hospital after having an acute event, those protein stores are depleted, making wound healing difficult.
Does the supplement offer benefits other than improving wounds?
Dr. Lee: Many versions of the protein supplement are being developed to help address those at risk, such as renal dialysis patients. There’s currently a study looking at how to give the supplement and not cause problems with patients who are on dialysis. That’s one of the real catch-22s: We know that a lot of the dialysis patients are at risk for wounds because they’ve got poor protein stores, but because they’re on dialysis you can’t give them a whole lot of protein—it makes their renal function even worse. It’s a delicate balance. There are some initial studies looking at a version of the supplement that can be used for dialysis patients without possibly creating a bigger problem.
Some formulations are designed for wound care specifically for tube feedings and for diabetics. There also have been some studies in which the supplement has been used with cancer patients to try to increase their lean body mass and get them to a point where they’re feeling much better and much healthier. Other formulations of the supplement are being developed to help improve the overall health of individuals.
Along with supplements, what can be done to improve wound healing in long-term care?
Dr. Lee: Three areas of wound care are important: nutrition, pressure relief, and the wound care itself. There’s been a huge change in the thought process of wound care. Because for so long it’s been based on tradition, there’s finally some push to get clinicians to understand that there are better ways of treatment. When you look at the science and the studies that have been out there for wound care, the bottom line is that moist wound healing, or keeping a wound covered and protected and maintaining moisture in the wound, will improve the healing process. We’ve been devoted to moist wound healing, which means applying dressings that actually can stay on and keep the wound covered, and we have seen much better healing rates.
What can facilities do to compensate for a lack of wound care expertise?
Dr. Lee: Wound care experts provide a valuable service to the nursing home setting. It is important to try to find someone, in particular a physician or even a wound care nurse, to help coordinate wound care protocols. That’s one of the things that we do, but nurse specialists and even physical therapists are now getting involved in wound care. You need to have somebody who knows what they’re doing and has made the effort to learn more about wound care. That may be as simple as sending a staff nurses to get more education and training. In fact, that is one of the things that the Medicare guidelines emphasize. You need to have someone in the nursing home facility—someone on staff—who’s been able to demonstrate some education or some effort to learn more about wound care and, more importantly, to understand the CMS guidelines.
What does your study mean for the future of wound care?
Dr. Lee: It’s raised the awareness that a protein supplement is not a protein supplement is not a protein supplement. There are huge differences in these products. People are beginning to look at these products, and say, “Maybe we need to track what’s going on here. Are we really getting the improvement in these wounds that we’re expecting?” In the near future hopefully, we, as well as other clinicians around the country, will do more clinical studies and more comparative studies to help clarify the questions of how do we take care of wounds, and how can we use something that will make a difference?
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