Wadagni AC, et al. - Considering persistence of surgery as an adjunct therapy for Buruli ulcer disease following the introduction of streptomycin and rifampicin for 8 weeks as standard care, researchers examined the effect of delaying the decision to operate to 14 weeks on rates of healing without surgery. This randomised controlled trial of patients (aged 3 years or older) with confirmed disease demonstrated a beneficial effect of delaying the decision to operate. Antibiotics alone can led even large ulcers to heal, without delaying healing rate and without an increase in residual functional limitations.

Methods

• Patients aged 3 years or older with confirmed disease were enrolled at one hospital in Lalo, Benin.
• Random assignment of patients (1:1) to groups assessing the need for excision surgery 8 weeks (standard care) or 14 weeks after initiation of antimicrobial treatment was performed.
• The number of patients healed without the need for surgery (not including skin grafting), was assessed as the primary endpoint in all patients in follow-up at 50 weeks (or last observation for those healed for >10 weeks).
• The indications for surgery according to predefined criteria was checked by a doctor masked to treatment assignment.

Results

• Researchers enrolled 119 patients from July 1, 2011, to Jan 15, 2015; two patients per group lost to follow-up.
• They noted healed lesions in 55 (96%) of 57 participants in the delayed-decision group and 52 (90%) of 58 participants in the standard-care group at 1 year after start of antimicrobial treatment (relative risk [RR] 1·08, 95% CI 0·97–1·19).
• The lesions healed without surgical intervention in 37 (67%) of 55 patients in the delayed-decision group, as did 25 (48%) of 52 in the standard-care group (RR 1·40, 95% CI 1·00–1·96).
• The two groups did not differ regarding the time to heal and residual functional limitations (median time to heal 21 weeks [IQR 10–27] in the delayed-decision group and 21 weeks [10–39] in the standard-care group; functional limitations in six [11%] of 57 and three [5%] of 58 patients; p=0·32).
• Reduced median duration of hospitalisation (5 days [IQR 0–187] vs 131 days [0–224]; p=0·024) and wound care (153 days [IQR 56–224] vs 182 days [94–307]; p=0·036) were evident with postponing the decision to operate.