Manuka honey vs. hydrogel--a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

摘要

OBJECTIVE: Comparison of desloughing efficacy after four weeks and healing outcomes after 12 weeks in sloughy venous leg ulcers treated with Manuka honey (Woundcare 18+) vs. standard hydrogel therapy (IntraSite Gel). BACKGROUND: Expert opinion suggests that Manuka honey is effective as a desloughing agent but clinical evidence in the form of a randomised controlled trial is not available. There is a paucity of research which uses Manuka honey in venous ulcers. DESIGN: Prospective, multicentre, open label randomised controlled trial. METHOD: Randomisation was via remote telephone. One hundred and eight patients with venous leg ulcers having >or=50% wound area covered in slough, not taking antibiotics or immunosuppressant therapy were recruited from vascular centres, acute and community care hospitals and leg ulcer clinics. The efficacy of WoundCare 18+ to deslough the wounds after four weeks and its impact on healing after 12 weeks when compared with IntraSite Gel control was determined. Treatment was applied weekly for four weeks and follow-up was made at week 12. RESULTS: At week 4, mean % reduction in slough was 67% WoundCare 18+ vs. 52.9% IntraSite Gel (p = 0.054). Mean wound area covered in slough reduced to 29% and 43%, respectively (p = 0.065). Median reduction in wound size was 34% vs. 13% (p = 0.001). At 12 weeks, 44% vs. 33% healed (p = 0.037). Wounds having >50% reduction in slough had greater probability of healing at week 12 (95% confidence interval 1.12, 9.7; risk ratio 3.3; p = 0.029). Infection developed in 6 of the WoundCare 18+ group vs. 12 in the IntraSite Gel group. CONCLUSION: The WoundCare 18+ group had increased incidence of healing, effective desloughing and a lower incidence of infection than the control. Manuka honey has therapeutic value and further research is required to examine its use in other wound aetiologies. RELEVANCE TO CLINICAL PRACTICE: This study confirms that Manuka honey may be considered by clinicians for use in sloughy venous ulcers. Additionally, effective desloughing significantly improves healing outcomes.