| Background The chronic ulcer of skin is a common disease, caused by local or systemic factors su ch as High blood sugar,acral ischemia, Neuropathy,Immune abnormalities and infection. people has paid much attention to it because of its seriousity and increasing incidence. Now, the conventional treatment includes autugraft, allograft and xenograft. But such three treatments have their respective defects. The source of autologous skin is very limited and might make new wound surface. Allograft and xenograft cound cause immunological rejection and spread diseases, so their application is restricted. Tissue engineering as a newly emerging science develop rapidly. Construction of tissue engineering skins provides a new method in treatment of the chronic ulcer of skin. Tissue engineering dermal substitutes offer a notable advantage,guaranteeing a greter clinical success in the procedures of wound healing. It cound take up good external appearance after wound healing. Many dermal substitutesa are in development or have been identified by FDA, such as Alloderm produced by Lifecell in 1995 have been applied to clinic widely. But Reports indicated that acellular dermal matrix cound cause immunological rejection and potentially dangerous infectious diseases, it sources are limited. Cell-free synthetic dermal matrix at the lack of extracellular matrix (ECM) components of acellular dermal matrix such as elastic fibers, proteoglycans and glycoproteins, and bovine collagen type I may stimulate the immune response, resulting in reduced graft survival rate. A new type of tissue- engineered acellular dermal substitute has been developed in Tissue Engineering Center of the Fourth Military Medical University. The greatest advantage of tissue-engineered acellular dermal substitute is that the structure of the extracellular matrix is close to natural structure, and its histocompatibilit is better than natural acellular dermal.Objectiv The purpose of the clinical trial is to investigating the clinical effects of tissue-engineered acellular dermal substitute in repairing of chronic skin ulcer, and finding a practical and feasible method of promoting the healing of chronic skin ulcer.Methods 24 patients with chronic skin ulcer in Out-patient clinic and ward were selected and enrolled in this study. After surgical debridement, ulcers (n=30) were randomly divided into experimental group and control group, tissue-engineered acellular dermal substitute was applied directly on the wound in experimental group(n=15) and vaseline dressing was applied on the wound in control group (n=15) respectively.All the patients were conventionally dressed and fixed. We Used Photoshop 8.0 image processing software for calculating ulcer area in each group. Analyzing statistically the healing time in each group (day),calculating and analyzing statistically the percentages of healing ulcer area in each group (%) at 2,4 and 6 weeks after operation. Observing changes in the course of treatment such as local wound inflammatory response, immunological rejection, evaluating qualityof ulcer healing after ulcer healing. We used SPSS 11.0 software for analysing difference between the two groups. Analysis of variance (ANOVA) or T test was applied for measurement date statistics ( x±s).Result The wound healing time in test group(28.13±4.42 days) was significantly shorter than that in control group(41.07±6.31days).The percentages of healing ulcer area in test group was Significantly larger that in control group. There was statistical significant diference between the two groups. There was no evidence of inflammatory response and immunological rejection in test group.Conclusion The chronic ulcer of skin could be repaired by tissue-engineered acellular dermal substitute in promoing the early healing, shortening the ill course and reducing its complications. It is practical and feasible for clinical application of tissue-engineered acellular dermal substitute.
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