A non-randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydropolymer wound dressing and smartphone technology: The EDISON trial protocol

Abstract

Total hip or knee arthroplasty is a highly effective intervention for treating the symptoms of degenerative joint disease or osteoarthritis (OA), often an unwelcome consequence of obesity. A safe and common surgical procedure, hip and knee arthroplasty procedures are not immune to the occurrence of postoperative complications such as surgical site infection (SSI) or surgical wound dehiscence (SWD). While published rates of SSI following hip or knee arthroplasty are low, 1% to 2% in some cases, it is the resulting wound complication and its clinical management and the impact on patient well-being and return to daily life for the 1% to 2% that is of concern. Postoperative complications such as SSI are a major cost driver to the health care system following arthroplasty and often result in extended lengths of stay, readmission for further surgery, primary and community nursing visits, and are a costly burden to health care settings. Early identification of a wound complication through post-discharge surveillance using a fully transparent dressing and smartphone technology and patient education may ameliorate contributing factors or reduce the likelihood of a complication occurring in the first instance. This clinical trial is a non-randomised pragmatic convenience sample carried out in 200 participants of both sexes receiving either a TKA or THA. There will be equal allocation to two groups (100 hips and 100 knees), with 50 in each allocation receiving the interventional dressing and 50 as control. The dressing will be applied prior to discharge and participants will be provided with education on postoperative wound care, when to contact home care nursing for a potential wound problem, and use of their smartphone to capture and send images of their incision site to the study nurses. Participants will also be followed up by home care nursing services at day 14 for suture removal and wound assessment. Participants will complete a patient-reported outcomes survey on day 14 and followed up on day 30 after surgery for wound assessment. The results of this trial may provide a novel pathway using a fully transparent dressing and digital technologies for the prevention of acute readmissions because of wound complications through early detection and intervention.