title: An RCT to compare a bio-cellulose wound dressing with a  non-adherent dressing in VLUs.
abstract: OBJECTIVE
  To compare the efficacy of a bio-cellulose dressing (BWD) versus a non-adherent wound contact layer in venous leg ulcer (VLU) outpatients.
  
  
  METHODS
  In a prospective, randomised, controlled multicentre study, 48 VLU patients were randomised to receive compression bandages and either standard care (non-adherent dressing; n=23) or a BWD (Suprasorb X; n=25). VLUs were evaluated for debridement efficacy, time to 75-100% granulation and ≥ 50% re-epithelialisation, reduction of ulcer size and patient-reported ulcer pain, comparing the status at day 0 and weekly, over a 12-week study treatment period.
  
  
  RESULTS
  Thirty-three patients (n=18 BWD and n=15 control dressing) were included in the analysis. Autolytic debridement was significantly faster in the BWD group, with an 84% removal of yellow tissue compared with 26% in the control group, over the 12-week period (p < 0.0001). A median of 25 days were required to achieve 75-100% granulation in the BWD group vs 36 days for controls. A median of 36 days was taken to achieve ≥ 50% re-epithelialisation in the BWD group vs 50 days for controls. Patient-reported ulcer pain reduced significantly faster in the BWD group (p < 0.05), by week 7, 100% of patients reported no pain, compared with 63% of controls.
  
  
  CONCLUSIONS
  Autolytic debridement was faster and more effective in the BWD group compared with standard care, as was pain reduction. Although the time to healing was shorter with the BWD vs standard care, the difference was not statistically significant.
  
  
  BACKGROUND
  This study was supported by Xylos Corporation. The study product was called X-Cell at the time, and is now available as Suprasorb X (Lohmann & Rauscher). Each principal investigator (Alvarez, Phillips, Menzoian, Etris-Brown) and respective clinical centre received funding for the conduct of the study. Each site executed a clinical study agreement independently with the sponsor. The sponsors had no role in the design and conduct of the study, in the collection, analysis, or interpretation of data, or in the preparation of the manuscript, review, or approval of the manuscript. None of the authors received administrative, technical or material support for the conduct of this study. The authors have no relevant financial interest in this article.
authors.forename: O M
authors.initials: OM
authors.lastname: Alvarez
authors.forename: T J
authors.initials: TJ
authors.lastname: Phillips
authors.forename: J O
authors.initials: JO
authors.lastname: Menzoian
authors.forename: M
authors.initials: M
authors.lastname: Patel
authors.forename: A
authors.initials: A
authors.lastname: Andriessen
mesh_terms: D000368:Aged; D002482:Cellulose / Q000627:therapeutic use*; D058128:Compression Bandages; D003646:Debridement; D005260:Female; D006097:Granulation Tissue / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009779:Occlusive Dressings; D010147:Pain Measurement; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing / Q000502:physiology*
chemical_list: D002482:Cellulose