Clinical Trial Report of Burns Regenerative Medicine and Therapy – a Multi-center Phase III Study

Xu RX. Burns Regenerative Medicine and Therapy, 1st ed., Basel: Karger; 2004. p. 119-128
 
In order to further examine and evaluate the therapeutic effects, main indications, and possible side effects of MEBO in burn treatment, this multi-center study was conducted as a phase III clinical trial.  In this trial, MEBO was used for treating vast numbers of burn patients of both sexes in varied ages, all suffering burns from different causes, occurring at different sites, encompassing varied areas, and injured to varied depths.  From January 1, 1996 to June 30, 1999, this phase III clinical trial was carried out at five burn centers of the China National Science and Technology Center for Burns, Wounds and Ulcers, located in Changsha, Taishan, Dalian, and Nanyang, China. 
 
Effects of MEBO on Burns Wounds Management: According to the results of this trial, MEBO promotes burn wounds healing in each depth of wound.  Remarkably, 99% of deep partial-thickness burn wounds healed spontaneously without skin grafting, at a very low scarring rate of 20.4% compared to 63.3% in the SD-Ag group.  Furthermore, in this trial, more than half of the clinically diagnosed full-thickness burns wounds could be healed spontaneously by MEBO without skin grafting.  MEBO provided burn wounds an optimum physiological environment for tissue regeneration and repair without further damage to viable tissue, subsequently, the wound would heal spontaneously with limited scarring, deformity, and disability.  Meanwhile, it was found that in the MEBOgroup, the incidence rate of wound infection was significantly reduced compared to that in the SD-Ag group, indicating that MEBOwas capable of preventing wound infection.
 
Analgesic Effect of MEBO: It was determined in this trial that throughout the treatment and during dressing changes, the analgesic effect and alleviation of pain in the MEBO group was dramatically superior to that of in the SD-Ag group.  Unlike SD-Ag which required painful peeling away of crusted and dried dressing from fragile tissue, MEBO neither aggravated the suffering and pain during the treatment and changing of dressing, nor did it fail to offer a satisfactory analgesic effect.  The need for an analgesic agent was rare in MEBO group.
 
Feasibility of Using MEBO for Treating Extensive Burns: In this trial, 75 extensive burn patients with TBSA >50% were treated with MEBO which resulted in a 100% healing rate whereby all patients were completely healed when discharged from the hospital.  No side effects and local or systemic allergic reactions were found.  In contrast, 2 of 31 extensive burn patients in the SD-Ag group died and 18 patients were discharged with unhealed residual wounds. 
 
Meanwhile, almost half of the extensive burns patients in the SD-Ag group were failing the treatment due to complications of wound infection, bleeding, severe painful or delayed healing, and had to switch into the MEBO group for ethical reasons, and, despite the relatively late access to MEBO, these patients achieved the same satisfactory results.  Therefore, it was concluded that treatment with MEBO for extensive burn patients was practical and safe.  In addition, it indicated that when the treatment with SD-Ag for extensive burn patients appeared to be unsatisfactory, switching them to MEBO was appropriate.  MEBO seemed to promote spontaneous healing in delayed-healing wounds and was able to free or decrease the needs of grafting.