An open label, prospective, randomized, comparative volunteer trial to compare the performance of the hydrocellular silicone gel adhesive* (HSGAF) wound dressing and alternative bilaminate island

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 clinicians’ needs. To that end the following clinical trial was undertaken. Methods: An open, prospective, randomized, comparative volunteer study was carried out to compare the performance of two wound dressings with silicone gel adhesives. The study investigated dressing retention, conformability, and clinical acceptability in 106 healthy volunteers over 7 days. Results: Dressing retention was significantly better for Hydrocellular Silicone Gel Adhesive than Alternative Silicone Adhesive dressings after 5 and 7 days wear on knees (12.6% difference, p=0.009 and 11.7% difference p=0.011, respectively) and 7 days on elbows (11.5% difference, p=0.002). Additionally, significantly more HSGAF dressings were rated by nurses to be clinically acceptable on knees after days 3, 5 and 7 (15.4%, p<0.001, 6.9%, p=0.021 and 5.8%, p=0.015, respectively). Clinical acceptability was defined as the absence of dressing lift compromising the protective barrier function of the dressing. Conclusions:  HSGAF dressing was shown to be superior to ASA dressing in terms of number of dressings in place on the knees at both days 5 and 7 and on the elbows at day 7. The results also suggest that HSGAF dressings have other properties such as adherence, conformability & clinical acceptability that are superior to ASA dressings. It is hoped that studies of this type will allow for enhanced clinician education, patient safety and prove beneficial to facilities.