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?