Assessment of Regenerative Therapy (MEBT/MEBO) in Healing of Various Open Wounds: A Multicenter Controlled Randomized Trial

Mahmoud F. Sakr¹, WANG Xiang-ning², FU Zi-jun², Hossam Hamed³ ,

Hesham El-Torky³

Department of Surgery, Faculty of Medicine, University of Alexandria, Egypt¹,

Burn and Plastic Department of Ya'an People's Hospital, Sichuan Province, China²,

and Surgical Division, Ahmadi Hospital, Kuwait³

ABSTRACT

Objectives: To assess the efficacy and safety of regenerative therapy (MEBO/MEBT) in healing of various acute and chronic open wounds. 

Subjects and Methods: Consecutive patients (n=276) with various open wounds (n=376) treated at 3 different hospitals, between 2009 and 2014, were randomized to receive either MEBT/MEBO (Group 1, n=141 with 190 wounds) or saline wet-to-moist dressing (Group 2 controls, n=135 with 186 wounds). Data collected prospectively included demographics, predisposing disease, co-morbidities, biochemical results, and wound characteristics. Surface area (SA) and healing index (HI) were calculated and compared at two-week intervals for 12 weeks, and secondary amputations were recorded at 24 weeks post-treatment.

Results: Open wounds included chronic pressure ulcers (CPUs) (n=202), diabetic foot ulcers (DFUs) (n=119), and miscellaneous group (n=55). 171 patients (63%) were male and 105 (37%) were female. Their ages ranged between 5-102 years, with a mean of 63±14.5 years. Patients in both groups had similar demographic, clinical, biochemical and wound characteristics. There was a significant increase in HI and reduction in SA starting at weeks two after initiation of treatment in patients treated with MEBT/MEBO. At 12 weeks, 66.3% of wounds (126/190) treated with MEBT/MEBO had complete healing (HI=1) as opposed to only 22.6% (42/186) of those treated with saline (X²=71.4, P=0.000). None of the patients receiving MEBT/MEBO had a HI of<0.5 at 12 weeks as compared to 38.7% (72/186) of those receiving saline (X²=165, P=0.000). No adverse or hypersensitivity reactions were encountered. At 24-weeks post-treatment, the rate of secondary amputations was significantly reduced by regenerative therapy (MEBT/MEBO) as compared to saline controls (3.3% versus 19%, respectively) (X²=7.52, P=0.006).

Conclusions: In addition to its simplicity and safety, MEBT/MEBO significantly promotes the healing of open wounds with significant increase in HI of any given wound, reflected by reduction of SA, as early as two weeks post-treatment, with complete healing (HI=1) of approximately two-thirds (66.3%) of wounds by 12 weeks and total effectiveness rate (HI >0.5) of 100%. At 24 weeks after initiation of treatment, patients with DFUs treated with MEBT/MEBO undergo significantly fewer secondary amputations than controls.

Correspondence to:

Mahmoud Sakr, MD, PhD, FACS

Professor of Surgery

Faculty of Medicine, University of Alexandria, Egypt