Therapeutic Treatment of 2A Grade Burns with Decellularized Bovine Peritoneum as a Xenograft: Multicenter Randomized Clinical Trial

Abstract

Background and Objectives: Homogeneous and xenogenic bioengineering structures are actively used as wound coatings in treatment of burns and have already shown their effectiveness. Nevertheless, the disadvantage of such dressings is their high cost. This issue is particularly challenging for developing countries in which the incidence of burns is the highest one. With such needs taken into account, the research team developed and clinically tested a new wound coating based on decellularized bovine peritoneum (DBP). Materials and Methods: A multicenter randomized clinical trial was conducted to evaluate DBP. The following variables were considered in the research study: the number of inpatient days, the number of dressing changes, the level of pain experienced during dressing changes, and the condition of wounds at the time of the follow-up examination. Results: The research involved 68 participants. It was found that the patients who were treated with a DBP experienced less pain with less changes of dressings. However, the number of inpatient days and wound healing failed to demonstrate statistically significant difference compared to the control group. Conclusions: In the given research, DBP showed efficacy in improving patients' quality of life by reducing pain and the number of dressings' changes. However, when comparing this research study with the studies of other animal-derived wound coverings, there were a number of differences and limitations in the parameters. Thus, the results requires further study for a greater comparability of data. Given the above, we expect that DBP will become an inexpensive and effective treatment for burns in developing countries.

Keywords: burns; decellularized bovine peritoneum; regeneration; wound dressing; xenograft.

Figure 1

Research design.

Figure 2

Participants of each group of study. (A) Patient of control group on the 1st day of trial, with 2A stage burns of anterior chest wall with boiled water, after debridement. (B) The same patient on the 3rd day of trial, and gauze bandages have adhered. (C) The same patient on the 14th day after discharge (20th day of trial). Re-epithelization of wound surface, with part of residual wound scab on the left side. (D) Test group patient on the 1st day of trial, with 2A stage burns of anterior chest wall with flame. (E) The same patient on the 3rd day of trial and total adherence of DBP, with drying. (F) The same patient on the 14th day after discharge (18th day of trial). Re-epithelization of wound surface. With small parts of residual wound scab on periphery of wound surface.

Figure 3

Electron micrograph of X-graft^® collagen fibers in longitudinal sections. Each fibril consists of regular alternating dark and light bands that are further divided by cross-striations. Scale bar is 200 nm.