Healing pressure ulcers with collagen or hydrocolloid: a randomized,controlled trial

OBJECTIVES: To compare the effects of topical collagen and hydrocolloid on pressure ulcer healing. DESIGN: Randomized (allocation concealed), single-blind (outcome assessors), controlled trial with 8-week follow-up. SETTING: Eleven nursing homes in central Illinois. PARTICIPANTS: Sixty-five patient-residents with Stage II or III pressure ulcers: median age 83.1, median Braden score 12, 63% female, 80% Stage II ulcers, and 20% Stage III ulcers. Exclusion criteria included cellulitis and osteomyelitis. INTERVENTION: Thirty-five patients were allocated to topical collagen daily, 30 to topical hydrocolloid twice weekly. MEASUREMENTS: The primary outcome was complete healing within 8 weeks. Secondary outcomes were time to heal, ulcer area healed per day, linear healing of wound edge, and cost of therapy. RESULTS: Analysis by intention to treat revealed similar complete ulcer healing within 8 weeks in collagen (51%) and hydrocolloid (50%) recipients (difference 1%, 95% confidence interval (CI) = 26-29%). Mean healing time was similar: collagen healed in 5 weeks (95% CI = 4-6), hydrocolloid healed in 6 weeks (95% CI = 5-7). Mean area healed per day was 6 mm(2)/d in both treatment groups. Mean linear healing of the wound edge was 3 mm in both groups. In multivariate analysis, baseline ulcer depth was the only independent predictor of complete ulcer healing within 8 weeks (odds ratio = 0.56, 95% CI = 0.38-0.81). Cost analysis favored hydrocolloid. CONCLUSIONS: There were no significant differences in healing outcome between collagen and hydrocolloid. Collagen was more expensive and offered no major benefits to patients otherwise eligible for hydrocolloid treatment.