A Recombinant Human Collagen Hydrogel For The Treatment Of Partial-thickness Burns: A Prospective,self-controlled Clinical Study

Background:The skin serves as an important defense organ in the human body.Trauma and burns can cause severe damage to the skin.In addition to obesity,diabetes,iatrogenic radiotherapy/chemotherapy,and other factors,the healing of skin wounds represents a major medical and financial burden.Allogeneic and xenogeneic skin grafts are typical treatments for skin wounds,but they currently face donor shortages.In addition,their quality is closely related to the condition of the donor,and specialized cryogenic containers/equipment are needed for their storage.Identifying a new treatment method that can be manufactured using industrial standards to replace allogeneic/xenogeneic skin can improve the quality of wound treatment and solve the problem of allogeneic/xenogeneic skin shortages.Many types of synthetic polymers and natural biological materials have been developed.Among them,collagen is an important extracellular matrix(ECM)component in human skin.Many studies have indicated that it has excellent biological activity that is closely related to the speed of wound healing and the extent of scarring after wound healing;it is also closely related to stem cell proliferation,migration,and skin aging.Moreover,scaffold materials containing collagen as the principal component have been widely used in clinical practice to promote the regeneration of dermal tissue in skin defects and wounds.In addition,collagen can significantly improve scar contracture after skin grafting and reduce the likelihood of dysfunction.However,the principal component of collagen products commonly used in clinical practice is animal-derived type I collagen,and the United States Food and Drug Administration clearly indicates that animal-derived materials carry the risk of transmitting viruses and spongiform encephalopathy.Recombinant collagen obtained from fermentation and purification based on gene transfection technology has been standardized for production.Our research group developed a hydrogel based on recombinant human type III collagen for the rapid cure of burn wounds,and its therapeutic effect on partial-thickness burns was evaluated in a self-controlled clinical trial compared to that of allogeneic skin.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 healingRESULTS:There were no statistically significant differences in wound healing outcomes 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 RHCHCONCLUSION: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.