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Study design
Design:
randomised controlled trial.
Allocation:
concealed.*
Blinding:
blinded (statistician).*
Study question
Setting:
vascular centres, leg ulcer clinics, and acute and community care hospitals.
Patients:
108 patients >18 years of age (mean age 68 y) who had a venous leg ulcer (VLU) <100 cm2 with [= or >, slanted]50% of the wound bed covered in slough. Exclusion criteria were malignant ulcer, wound infection, presence of a cavity wound, use of antibiotics or oral immunosuppressants, poorly controlled diabetes, pregnancy or lactation, and previous enrolment in the study.
Intervention:
Wounds were cleansed with warm tap water and then treated with 5 g/20 cm2 Manuka honey (n = 54), or 3 g/20 cm2 hydrogel therapy (n = 54), weekly for 4 weeks. Use of Allevyn hydrocellular foam as secondary dressings and compression therapy continued throughout the treatment period. Treatment after week 4 was determined by the local investigator.
Outcomes:
VLU desloughing at 4 weeks and wound healing at 12 weeks.
Follow-up period:
12 weeks.
Patient follow-up:
100% in intention-to-treat analysis.
Main results
At 4 weeks, groups did not differ for rate of reduction of slough or percentage of the wound bed...