Patient Opinion on Dermal Replacement Products

Introduction It is estimated that over 1.2 million people are burned in the United States each year with approximately 60,000 of these victims requiring hospitalization for treatment.[1] Due to the physiological instability produced by a loss of skin and limited sources of natural skin, there is a great need for the development of synthetic skin in order to save patients with high total body surface area (TBSA) full-thickness burns. As the TBSA increases, the amount of skin available as donor sites decreases, and new options are needed to permanently close the wound. Many skin substitutes have been developed, but the two most commonly used for definitive closure of full-thickness burns are Integra™ Artificial Skin (AFS) (Johnson and Johnson Medical, a Division of Ethicon, Arlington, Texas) and AlloDerm® Acellular Tissue (ACT) (LifeCell Corporation, Branchburg, New Jersey). Both dermal replacements are frequently used to close full-thickness wounds regardless of size. Full-thickness burns extend through the dermis and into the subcutaneous fat. Due to the extensive injury of the dermal layer, a graft is needed that can permanently replace the nonregenerative dermis. An autograft ranging from 0.010 to 0.016 of an inch in depth contains enough dermis to replace the wound but leaves the patient with a second wound that can cause further trauma to the body. Both AFS and ACT allow for thin epidermal autografts of approximately 0.005 of an inch.[2] AFS is a dermal regeneration template engineered by LifeSciences Corporation and approved by the Food and Drug Administration in March of 1996. It is a bilayer membrane composed of a dermal section, which consists of a porous lattice of fibers made of bovine collagen crosslinked with a glycosaminoglycan/chondroitin-6-sulfate composite and an epidermal layer of synthetic polysiloxane polymer or silicone.[3] The dermal layer of AFS serves as a biodegradable template that induces regeneration of dermal tissue by providing a structure in which fibroblasts, lymphocytes, macrophages, and endothelial cells can form a neovascular network. The fibroblasts deposit native collagen as the healing process progresses, while the artificial collagen portion of the AFS is biodegraded over approximately 30 days.[3] Immediate wound homeostasis is provided by the epidermal layer of the AFS acting as normal skin by controlling moisture loss from the dermis and providing an overall strength to the AFS graft. As the dermal layer remodels beneath it, the epidermal layer remains intact until it is surgically removed and replaced. In order for the AFS to adhere to the healthy skin surrounding the burn, the wound must be excised to a level of viable tissue, and meticulous hemostasis must be achieved.[4] AFS provides the patient with numerous clinical advantages, including immediate physiologic wound closure, no immediate requirement for skin donor sites, atraumatic removal of the silicone layer, and no typical rejection of the silicone layer (Figure 2). AFS can remain intact for up to 73 days without adverse effects, allowing the patient to stabilize before undergoing an autograft procedure. This allows possible future donor sites to heal.5 Additionally, any required donor sites heal quicker than with a conventional autograft because the epidermal autograft needed is only approximately 0.005 of an inch in depth compared to the thicker conventional autograft of 0.010 to 0.016 of an inch.[3] Some drawbacks to AFS include the following: It will not adhere to the wound bed if even a minute amount of eschar is present or if hemostasis is not achieved; it is subject to sepsis, fluid accumulation, and/or infection; and the treatment requires two separate surgeries. In a clinical trial involving 228 burn patients, infection rates related to the use of AFS ranged from 14 to 55 percent, causing either a partial or complete loss of the graft.[3] An alternative to AFS is ACT‚ which is designed to be an immunologically inert acellular matrix. ACT is a chemically treated cadaver allograft that is processed to remove all epidermal antigenic cellular components while preserving the remaining dermal matrix.[2] Initially, donor tissue is screened for possible immunodeficiency viruses, syphilis, and hepatitis B and C. ACT has been in use for seven years and in those seven years of use, with more than 50,000 grafts, there has not been one reported case of a virus or a disease being transmitted to a patient because of ACT.[6] If the donor tissue passes this screening, the epidermal layer is separated from the dermal layer using a high-salt solution while maintaining the basement membrane of the dermis.[2] Low molecular weight nondenaturing detergents are used to remove cells from the dermis, and the matrix is stabilized through the inhibition of metalloproteinases. The removal of all cellular components makes the tissue immunologically inert and decreases the chance of tissue rejection by the recipient’s body.[7] Finally, the tissue is treated with a freezing medium and then freeze-dried for storage without damaging the matrix proteins or disrupting the basement layer of the dermis.[2] As in the surgical procedure with AFS, the burn wound is debrided and excised to a level of viable tissue, and meticulous hemostasis is maintained. The ACT is then cut and applied to fit the size and contours of the wound, and, unlike AFS, an ultrathin split-thickness autograft of 0.004 to 0.006 of an inch in depth is secured with staples immediately over the ACT in the same surgery.[2] The acellular dermal matrix of ACT serves as a biologic scaffold to incorporate the cell repopulation and revascularization by the recipient’s body. Fibroblasts start to produce connective tissue that intertwines the matrix with the recipient’s own tissue, which, therefore, allows complete wound closure.[7] Unlike AFS, ACT only requires one surgery; therefore, the patient should have a shorter hospital stay and lower hospital bill. ACT also allows for the use of ultrathin-thickness autografts, leaving the patient with more superficial donor site wounds than conventional grafts. Some disadvantages to Act are prevalent when dealing with a patient who has a high TBSA burn. ACT requires an immediate autograft during surgery, so if the patient does not have enough skin to donate, AFS is a practical alternative. As with the AFS, ACT will not adhere to the wound bed if eschar is present or hemostasis is not achieved before placement. In the authors’ unit, when a patient has a burn that is approximately 20-percent TBSA or below, the patient is given the choice of AFS, Act with thin autograft, or conventional autograft to cover the burn. Many factors, such as cosmetic appearance, functionality, amount of scarring, length of hospital stay, number of surgeries, length of time until returning to work, hospital personnel, and manufacturer pamphlets or videos influence the patient’s decision of which graft to use. This study analyzes the extent to which each factor affects patients’ decisions of which graft to use and their satisfaction with the surgical results. The results were compared between the AFS and ACT, searching for a significant difference in the influences affecting patients’ decisions and subsequent satisfaction with various aspects of the skin graft. When a patient has a burn that is greater than 20-percent TBSA, the decision of which graft to use is made by the surgeon, depending on the patient’s condition and location of burns. It is not unlikely that the patient will have both dermal replacement products utilized in his or her care. Another goal of this study was to determine if these patients have a preference for one substitute or the other. Materials and Methods When either Act or AFS is used on a patient, the patient is financially charged using a number specific to AFS or ACT Patients were selected out of a computer database of hospital records by the charge number specific to either ACT or AFS from April of 1997 through October of 2001. The total number of patients selected was 144, which includes patients that have used these skin substitutes on both burns and wounds. All 144 charts were located and their files reviewed for inclusion in this study. All patients who used AFS or ACT for nonburn wounds, burn patients who had expired, and those who had over a 20-percent TBSA burn and were not grafted with both AFS and Act were excluded from the study. Forty-seven patients qualified for the study involving patients with TBSA under and including 20 percent, while only 18 qualified for the study of patients receiving both ACT and AFS. Burn diagrams were constructed for all 65 patients using the widely accepted “rule of nines” method. This method allows calculation of the TBSA of a burn by the body being divided into anatomic regions that have surface area percentages in multiples of nine percent.[8] These diagrams were utilized to remind the patient which type of skin substitute was used and where it was placed on the body. The patients were contacted by phone to complete a standardized survey. One set of questions was asked of patients in the 20-percent TBSA and below category (Figure 1) and a different set used for patients that had both ACT and AFS applied (Figure 2). The patients’ responses were then entered into a spreadsheet database and analyzed. A chi-square test was performed on each of the data categories to determine the existence of significant statistical differences among the data, and various trends were analyzed for patterns.[9] Results Patients receiving AFS and/or ACT grafts were selected as described in Materials and Methods. After selection, they were interviewed via telephone and their responses recorded and then analyzed. Table 1 and Figures 3 through 10 summarize the patient responses concerning the influence of various factors on patient decision of which skin substitute to use; Table 2 and Figures 11 through 13 summarize patient satisfaction with various factors after surgery. Due to the small population size, responses of patients shown in Tables 1 and 2 were regrouped into larger categories. Results are shown in Tables 3 and 4, respectively. Tables 1 and 3 summarize the responses concerning factors influencing patient choice of graft. Using the chi-square test, statistical analyses of the responses from patients receiving ACT were not significantly different from those of patients receiving AFS. Note, however, the large number of individuals who apparently did not receive/read manufacturer pamphlets (19 out of 31) and the apparent overwhelming importance of medical personnel (22 out of 31). Tables 2 and 4 summarize the results of the patient satisfaction with grafts after surgery. Results were again analyzed using the chi-square test, and no significant differences were found between responses of patients receiving AFS or ACT. Note that in terms of the number of surgeries undergone during treatment, 14 out of 15 ACT patients and 13 out of 16 AFS patients were at least moderately satisfied with the number of surgeries they endured, despite the fact that AFS requires an additional surgery. The patients queried above received either AFS or ACT grafts, so they had little basis to compare one type of graft versus the other. However, patients who had received both types of grafts have a basis for such a comparison; therefore, the available population receiving both types of grafts were interviewed. Table 5 lists and Figure 14 visually portrays the degree of satisfaction of each such patient with both his or her ACT and AFS grafts. No statistically significant differences using the chi-square distribution were found between patient response comparing the two types of grafts. The assumption was made that if the two types of graft were equal, then the distribution of “being higher” should be random. That is, 50 percent of the time ACT should be rated higher and 50 percent of the time AFS should be rated higher. Using the chi-square distribution to examine the results in Table 5, there appeared to be no reason not to accept that the grafts were equal. Table 4 shows that eight out of the 12 patients thought AFS worked better, but only seven out of the 12 recommended AFS over Act to other patients. Four patients believed ACT worked better for them, but five out of 12 patients would recommend ACT over AFS to other patients. Discussion Although based on a very limited sample size, no statistically significant differences were found among factors influencing patient choice of skin graft nor in patient satisfaction with the results of the grafts. In addition, there was no statistical evidence for a trend in satisfaction for either type of graft. Several results, however, deserve comment. They may be classified in three categories as follows: 1) lack of “logical” correlations, which may be caused by lack of information; 2) the importance of healthcare personnel; and 3) unexplained inconsistencies. Lack of logical correlations. There are several significant procedural differences between ACT and AFS that one anticipates may cause a patient to prefer one over the other. For example, the fact that AFS requires a minimum of two surgeries while ACT requires only one may cause a patient to prefer ACT. Consequently, it could be expected that patients choosing Act would score concern over the number of surgeries higher than those who chose AFS. However, according to survey results (Table 3), the patients who chose AFS were as concerned with the number of surgeries involved as the patients who chose ACT. This is different from what would be expected. One explanation for equal concern for the number of surgeries may come from the way the patients remember how the two skin substitutes were presented to them. Multiple times throughout the survey process, some patients who chose AFS mentioned they were unaware that ACT required fewer surgeries; therefore, they rated the importance of the number of surgeries as high as those patients who knowingly chose ACT to avoid numerous surgeries. Note also that two patients receiving ACTchose Not Applicable (NA) as their response because they believed that they were not given any choices in which skin substitute to use and that their physicians made the decision. They claimed they were unaware that a choice existed; therefore, they could not contribute to what would have influenced their decisions. Similarly, since the length of a hospital stay is often linked with the number of surgeries a patient endures, one would expect the length of the hospital stay to have more influence on the patients who chose ACT over those who chose AFS. Once again, the influence that the length of hospital stay had on the AFS patients was equal to that of the ACT patients (Table 3). The same two patients that answered NA to the influence of the number of surgeries required answered NA to the length of the hospital stay for the same reasons described above. Role of healthcare professionals. The influence a healthcare provider has through his or her presentation of the different skin substitutes or outright recommendations and advice is stupendous. All but one patient in the AFS group and one in the ACT group placed the influence of the healthcare providers as having at least moderate influence on their decisions of which substitute to choose (Table 3). The fact that 13 out of 15 ACT patients and 14 out of 16 AFS patients rated the physician as having the two highest possible influence ratings on their decisions, and only four ACT and nine AFS patients rated the nurses as high as the physicians, which shows that the opinion of the physician is regarded much higher and carries more weight than that of the nurse. This is further confirmed with 11 ACT patients who placed nurse influence in the lowest category and five AFS patients who labeled nurse influence as NA. This would imply that nurses either never went over patient options or the patients did not recall such conversations. The extraordinary amount of influence healthcare providers have on patient decision regarding what skin substitute to choose may be the key to understanding the majority of the survey results. Unfortunately, the different options of skin substitutes are not presented to patients in a standardized manner since there are two surgeons and multiple different nurses interacting with the patients. This makes it difficult to analyze the survey results. It is not uncommon for the healthcare provider, whether it is a physician or a nurse, to recommend one substitute over another and the patient not remember the explanation of the less preferred option. Throughout the phone survey, many patients commented that the physician chose the type of skin substitute to use and that the patients did not feel they were ever given a choice in the matter despite the facility’s surgeons’ convictions that they were impartial. Some of the patients expressed anger when told during the survey that they had another option with fewer surgeries. Importance of the physician is also apparent from the fact that most of the subjects in both populations did not remember being exposed to information from other sources, e.g., a manufacturer’s video or pamphlet (Table 2). Almost every time a manufacturer pamphlet was recalled being given to the patient or a video being watched, it had a fairly high influence on the patient decision of which substitute to choose. The pamphlets and videos may be untapped resources the medical care personnel should use more frequently and repeatedly to provide patients with more information, thereby facilitating more informed decisions. Unexplained inconsistencies. There are a few “internal inconsistencies” that indicate the questionnaire may have had some design problems. For example, six patients rated AFS better with respect to cosmetics versus two for ACT. The numbers were reversed for the amount of scarring. The simplest explanation is that the reversal in the scoring scales was not noted by the patients. This would be a questionnaire design flaw that should be corrected in any follow-up study. Another indication the questionnaire had flawed questions is that almost half of the people surveyed, 15 out of 31, were not concerned with the length of time until they could return to work. Thirteen of the 15 were minors with either no employment or with part-time jobs that would be flexible with their absences. Hence, these responses to this question simply reflect the fact that returning to work was virtually meaningless to them. Summary Conclusions and Recommendations Results of this study show that patients are either not well informed regarding options for synthetic skin grafts or do not remember what they are told. In addition, it is hard to overestimate the influence physicians have on patients’ eventual choices. This suggests that physicians must exercise great care in educating their patients and must take their responsibility to explain the options very seriously, recording such discussions in patient charts. Moreover, if the two grafts are equal in terms of patient satisfaction (a conclusion that may have to be modified based on the apparent lack of patient knowledge) then such equality should be noted to the patient as well. That is, patients should be told that other patients are equally satisfied with the alternative grafts. If both skin substitutes give similar results, a patient might be more inclined to choose the option with fewer surgeries and a possible shorter hospital stay. This may be particularly important when deciding which option to use on young children or the elderly; it may be preferable for these two groups, in particular, to undergo the physical and emotional trauma of a surgery only once.