Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU)

BMJ Open
Andrew JullJill Waters

Abstract

To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing. Pragmatic parallel group randomised controlled trial. Community-dwelling 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). Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression. 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. 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 i...Continue Reading

Associated Clinical Trials

References

Nov 1, 1991·The Australian and New Zealand Journal of Surgery·M C StaceyN L Browse
Aug 11, 2000·The American Journal of Medicine·D J MargolisB L Strom
Jul 14, 2004·Health Technology Assessment : HTA·C IglesiasUNKNOWN VenUS Team
Sep 24, 2004·The British Journal of Surgery·E A NelsonUNKNOWN VenUS I collaborators
Feb 18, 2005·Biology of the Cell·Maria I Morasso, Marjana Tomic-Canic
Dec 29, 2007·The British Journal of Surgery·Andrew JullUNKNOWN Honey as Adjuvant Leg Ulcer Therapy trial collaborators
Aug 23, 2008·Journal of the American Academy of Dermatology·Carlos A CharlesRobert S Kirsner
Mar 24, 2009·BMJ : British Medical Journal·Jo C DumvilleUNKNOWN VenUS II team
Mar 8, 2011·Health Technology Assessment : HTA·J M WatsonUNKNOWN VenUS III team
Dec 16, 2011·International Wound Journal·Alejandra C VivasRobert S Kirsner
Feb 16, 2012·Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society·Patricia M PechterStephen C Davis
Mar 4, 2014·International Wound Journal·Annette T BatzerRobert S Kirsner
Jul 18, 2014·Advances in Wound Care·Irena PastarMarjana Tomic-Canic

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Methods Mentioned

BETA
biopsies
biopsy

Software Mentioned

Research Electronic Data Capture ( REDCap )
SAS

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