BMJ open · 2020
Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU).
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАPragmatic Clinical TrialНазвание и аннотация: Перевод в очереди
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Jull Andrew, Wadham Angela, Bullen Chris, Parag Varsha, Weller Carolina, Waters Jill
Аннотация
OBJECTIVE: To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.
DESIGN: Pragmatic parallel group randomised controlled trial.
SETTING: Community-dwelling participants.
PARTICIPANTS: People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both).
INTERVENTION: Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.
PRIMARY AND SECONDARY OUTCOME MEASURES: Healing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.
RESULTS: We screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm2, 95% CI -16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI -12.4% to 24.9%).
CONCLUSION: The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.
TRIAL REGISTRATION NUMBER: NCT02896725.
DESIGN: Pragmatic parallel group randomised controlled trial.
SETTING: Community-dwelling participants.
PARTICIPANTS: People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both).
INTERVENTION: Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.
PRIMARY AND SECONDARY OUTCOME MEASURES: Healing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.
RESULTS: We screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm2, 95% CI -16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI -12.4% to 24.9%).
CONCLUSION: The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.
TRIAL REGISTRATION NUMBER: NCT02896725.