An open, prospective, randomized, comparative volunteer trial to compare the performance of the hydrocellular silicone gel adhesive wound dressing and alternative bilaminate island silicone dressings

Purpose: A necessary part of research and product development is testing to determine if initial goals are being met. True in use data is key in meeting the patients’/clinicians’ needs. To that end the following clinical trial was undertaken. Methods: An open, prospective, randomized, comparative volunteer trial to evaluate and compare the performance of the hydro cellular silicone gel adhesive wound dressing and a bilaminate island silicone dressing in terms of dressing lift to pad and other performance parameters. The study was conducted on one hundred healthy volunteers over a period of seven days.   Results:  There was significant evidence of fewer Hydrocellular Silicone Gel Adhesive (HSGA) wound dressings (compared to Bilaminate Island Silicone (BIS) dressings) lifted to the pad after 1 day (28% vs 80%, p<0.001), 3 days (42% vs 96%; p<0.001) and 7 days (57.6% vs 97%, p<0.001). More HSGA dressings were fully adhered compared to BIS on day 1 (65% vs 17%), day 3 (53% vs 3%) and day 7 (33.3% vs 1%). After 7 days wear, the majority of HSGA dressings remained adhered compared to a minority of BIS (76.5% vs 10.2%, p<0.001). There was little difference between dressings in the remaining parameters assessed (ease of application and removal, conformability, and comfort during wear).  Conclusions: HSGA dressing was consistently shown to be superior to BIS in terms dressing retention after 1, 3 and 7 days wear. It is hoped that studies of this type will allow for enhanced clinician education, patient safety and prove beneficial to facilities.