Comparison of the Risk of Surgical Site Infections Between Dressings Stopped at Postoperative Day 1 vs Dressings Stopped at Postoperative Day 6+/-1 After Elective Abdominal Surgery
NCT Number: NCT06569862
Acronym: PAN-STOP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elective Abdominal Surgery
Interventions: PROCEDURE: Postoperative day 1 dressing|PROCEDURE: Postoperative day 6+/-1 dressing
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1288
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-12
Locations: Hôpital de la Pitié-Salpêtriere - APHP, Paris, 75013, France

Summary:
The daily changing of postoperative dressings is a widespread practice, often continuing until the 5th-7th day after surgery. In theory, dressings aim to reduce the risk of superficial surgical site infections (SSIs). However, several studies have suggested that early removal of the dressing does not significantly impact the rate of superficial SSIs, and this approach is now applied in clinical practice by several teams. A Cochrane review indicated that the absence of dressing does not appear to be harmful, though it emphasized the very low level of evidence provided and the need for high-quality randomized controlled trials. In this study, the investigators aim to provide high-level evidence on the effect of stopping dressings from the 1st postoperative day and the lack of impact on the risk of SSIs, to standardize practices and enable recommendations.

Primary Outcome Measures: Proportion of superficial surgical site infections (SSI), The percentage of superficial surgical site infections (SSI) within the 30 days following surgery, defined according to the criteria set by the Centers for Disease Control and Prevention (CDC)., Day 30 post-surgery
Secondary Outcome Measures: Direct and indirect costs, Medical-economic impact, Day 30 post-surgery|Rate of repeat surgery, 30 days post-surgery|Rate of unscheduled nursing care, 30 days post-surgery|Percentage of patients who asked for their scars to be covered, 30 days post-surgery|Total length of hospital stay, 30 days post-surgery|Overall morbidity rate according to Clavien-Dindo, 30 days post-surgery|Rate of antibiotic treatment, 30 days post-surgery|Quality of life for patients, Patient's quality of life on days 6 and 30 post-surgery as assessed using the EuroQol Research Foundation 5 Dimensions Self-Questionnaire (EQ-5D-5L)., Day 6 and Day 30 post-surgery|The incremental cost-effectiveness ratio (ICER), The incremental cost-effectiveness ratio (ICER) measures the costs (from the healthcare system perspective) per infection prevented between the intervention and control arms 30 days after inclusion. It is calculated as the difference in average costs between the two arms divided by the difference in average number of infections between them., 30 days after inclusion|The incremental cost-utility ratio (ICUR), The incremental cost-utility ratio (ICUR) assesses the costs (from the healthcare system perspective) per Quality-Adjusted Life Year (QALY) gained between the intervention arm and the control arm 30 days after inclusion. Quality of life is evaluated using the EQ-5D-5L scale (EuroQol Group) at the inclusion visit, discharge from hospital, and at 30 days, covering five dimensions (mobility, stress/anxiety, ability to perform daily activities, autonomy, pain/discomfort). ICUR is calculated as the difference in average costs between the two arms divided by the difference in average QALYs gained between them., 30 days after inclusion