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
- Conditions
- Elective Abdominal Surgery
- Registration Number
- NCT06569862
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 1288
Inclusion Criteria:<br><br> - Patient of legal age (=18 years)<br><br> - Scheduled for elective abdominal surgery requiring a skin incision of at least 4 cm<br> long listed below:<br><br>All pancreatectomies, All hepatectomies, All splenectomies, All adrenalectomies, All<br>bariatric surgeries, All gastric surgeries, including gastrectomy and reflux surgery, All<br>parietal surgeries; ventral hernia repairs, inguinal or femoral hernia repairs, with or<br>without mesh placement..<br><br>All small bowel resections, Laparotomy cholecystectomies, All duodenal surgeries, Right,<br>transverse or left colectomy, by laparotomy or laparoscopy, provided that there is a skin<br>incision for extraction of the surgical specimen, but without the presence or creation of<br>a stoma Proctectomy but without the presence or creation of a stoma<br><br> - Class I or II (clean or clean-contaminated) according to the ALTEMEIER<br> classification<br><br> - Affiliated in a Social Security scheme (beneficiary or entitled person, excluding<br> AME)<br><br> - Have signed an informed consent form<br><br>Exclusion Criteria:<br><br> - Presence or completion of a stoma<br><br> - Previous abdominal surgery in the month prior to inclusion<br><br> - Emergency surgery<br><br> - Outpatient surgery<br><br> - Trocar holes<br><br> - Closure by biological glue<br><br> - Active bacterial infection at the time of surgery or recent antibiotic therapy (up<br> to 15 days before surgery)<br><br> - Neutrophil count < 500/mm3 at time of surgery<br><br> - Grade B or C cirrhosis (Child-Pugh classification)<br><br> - Pregnancy<br><br> - Breast-feeding<br><br> - Patient under guardianship or curatorship<br><br> - Patient deprived of liberty by judicial or administrative decision<br><br> - Patient unable to perform perioperative care
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of superficial surgical site infections (SSI)
- Secondary Outcome Measures
Name Time Method Direct and indirect costs;Rate of repeat surgery;Rate of unscheduled nursing care;Percentage of patients who asked for their scars to be covered;Total length of hospital stay;Overall morbidity rate according to Clavien-Dindo;Rate of antibiotic treatment;Quality of life for patients;The incremental cost-effectiveness ratio (ICER);The incremental cost-utility ratio (ICUR)