A Recombinant Human Collagen Hydrogel For The Treatment Of Partial-Thickness Burns: A Prospective, Self-Controlled Clinical Study

Introduction: Allogeneic and xenogeneic skin are recognized as the best coverings for skin burn wounds, but currently face a supply shortage. To solve this problem, our research group developed a standardized manufactured hydrogel dressing based on a new type of highly bioactive recombinant human collagen.Study design: Prospective self-controlled trial.Objective: To evaluate the efficacy and safety of recombinant human collagen hydrogel in the treatment of partial burn wounds to the skin compared to those of xenogeneic skin.Methods: This study included twenty-one patients admitted to Shanghai Changhai Hospital within 48 h after receiving partial-thickness skin burns. The wounds were symmetrically separated along the axis and treated with recombinant human collagen hydrogel (RHCH) or a human-CTLA4-Ig gene-transferred pig skin xenotransplant. The condition of the wound surfaces was recorded on days 0 (of enrollment), 5, 10, 15, and 20, and bacterial drug sensitivity testing, hematuria examination, and electrocardiographic tests were conducted on days 0, 10, 20, or on the day of wound healing.Results: There were no statistically significant differences in wound healing time between the two groups. The median number of days to healing was 11.00 +/- 0.56 for xenogeneic skin vs. 11.00 +/- 1.72 for RHCH.Conclusion: During the observation period, the therapeutic effect of the RHCH developed by our group on partial-thickness burn wounds was not significantly different from that of gene-transferred xenogeneic skin. Thus, our designed RHCH shows potential for clinical use to treat burn wounds on the skin. (C) 2020 Elsevier Ltd and ISBI. All rights reserved.