A Controlled Randomized Trial Assessing Regenerative Therapy in Healing of Chronic Pressure Ulcers
Method: Consecutive patients (n=105) with CPUs (n=218) treated at three different hospitals were randomized to receive Moist Exposed Burn Ointment (MEBO) dressings (Regenerative group, n=55 with 115 ulcers) or wet-to-moist saline dressings (Control group, n=50 with 103 ulcers). Data collected prospectively included demographics, clinical, biochemical and ulcer features. Ulcer surface area (SA) and healing index (HI) were calculated and compared at twoweek intervals for 12 weeks. Results: Sixty-one patients (58.1%) were male and 44 (41.9%) were female. Their mean age was 69.5 years. There was an increase in HI and reduction in SA starting at two and four weeks, respectively in the regenerative group. At 12 weeks, 61.7% (71/115) of ulcers treated with MEBO had complete healing (HI=1) versus 28.2% (29/103) of controls (p=0.000). None of the patients receiving MEBO had a HI of<0.5 at 12 weeks as compared to 25.2% of controls (p=0.000). Significantly (p<0.01) more grade 2-4 ulcers healed completely with MEBO by 12 weeks. No adverse effects or allergic reactions were noted by 12 weeks. Conclusion: In addition to its safety, MEBO significantly promotes the healing of CPUs with significant increase in HI of any given ulcer as early as two weeks of treatment, and significant reduction of ulcer SA starting at four weeks with complete healing of more than 60% of ulcers by 12 weeks.