MEBO study

【Abstract】Objectives A multi-centers, randomized, controlled study to assess the efficacy and safety of MEBO (Julphar Gulf Pharmaceutical Industries, UAE, and SanTou MEBO Pharmaceutical CO., LTD., China) in healing of chronic pressure ulcers. Subjects and Methods Eighty seven patients with 182 chronic pressure ulcers treated at five hospitals from different areas in world, between January 2003 and January 2009, were randomized into 2 groups; those in group 1 (n=46) received MEBO while those in group 2 (n=41) received Fucidin (Leo Pharmaceutical, Denmark).  Data collected prospectively included demographics, nutritional status, underlying predisposing disease and co-morbidities. Ulcer surface area (SA) and healing index (HI) were calculated and compared at two-week intervals for 12 weeks. Results Patients in both groups had similar demographic, clinical, biochemical features, and ulcer characteristics. There was a significant increase in HI and reduction in ulcer SA on weeks two and four respectively, that was maintained through 12 weeks in patients treated with MEBO. More than half of ulcers (56.5%) treated with MEBO had complete healing (HI = 1) by 12 weeks, as opposed to only 19.6% of those treated with Fucidin (P<0.001). Moreover, none of the patients receiving MEBO had a HI of <50% of their ulcers by 12 weeks as compared to 26.8% of those receiving Fucidin (P<0.001). No adverse effects or allergic reactions of topical ointment were encountered in either group. Conclusions In addition to its safety, MEBO significantly promotes the healing of chronic pressure ulcers with significant increase in HI of any given ulcer as early as two weeks following initiation of treatment, and complete healing of more than 50% of ulcers by 12 weeks.
【Key Words】MEBO; physiological moist environment; regenerative medicine; pressure ulcers; chronic wounds; healing index
【Article identifier】doi：10.3969/j.issn.1001-0726.2011.01.010

INTRODUCTION
Pressure ulcers, defined as any lesion caused by unrelieved pressure resulting in damage of underlying tissue, constitute a clinical challenge for both the clinician and the patient[1]. Healing is unpredictable, it often stalls due to such local factors as sepsis, edema, and prolonged pressure; and to systemic factors such as diabetes mellitus, smoking, anemia, poor nutrition, obesity, cancer, ischemia, uremia, and denervation. Chemotherapeutic agents, corticosteroids and tissue irradiation also lead to delayed wound healing[2~3].
There is, however, recent evidence in the literature that good hydration is the single most important external factor responsible for optimal wound healing[4~6]. Moist Exposed Wound Ointment (MEBO) (Julphar Gulf Pharmaceutical Industries, UAE., and SanTou MEBO Pharmaceutical CO., LTD., China) reduces evaporation from the wound surface, thereby offering a moist environment for wound healing[7]. It has no evident negative effect on the immune defense mechanisms[8], and has a similar action in-vivo to Silver Sulfadiazine in controlling burn wound sepsis and systemic infection with P. aeroginosa[9]. It has also been shown experimentally that MEBO exhibited a significantly superior wound healing potential on rabbit corneal epithelium as compared to saline, homologus serum, vitamin A and dexamethasone[10], as well as on rabbit skin burns treated with Vaseline[11]. Moreover, MEBO has been found to be extremely beneficial in the treatment of partial thickness facial burns[12], and split thickness skin graft donor sites[13], and for the healing of experimentally induced CO2 laser burns in animals[14].
The present randomized clinical study was therefore conducted to assess the efficacy and safety of MEBO as compared to topical antibiotic ointment (Fucidin, Leo Pharmaceuticals, Denmark) in the local wound care and healing of chronic pressure ulcers.