Stopping surgical dressings on day 1 versus day 6 after elective abdominal surgery
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: a Multicentre Non-inferiority Randomized Controlled Trial
This test will see if removing the wound dressing on the first day after elective abdominal surgery is as safe for adults as leaving it on until about day six.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1288 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06569862 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two postoperative dressing strategies for adults having elective abdominal operations with a skin incision of at least 4 cm. Participants will be assigned to have their surgical dressing removed on postoperative day 1 or retained until postoperative day 6 ±1, and rates of superficial surgical site infections will be recorded. The trial focuses on clean or clean-contaminated procedures across common abdominal surgeries to provide higher-quality evidence on dressing duration. Results are intended to help standardize postoperative dressing practices and guide recommendations.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for specified elective abdominal operations with a skin incision ≥4 cm and classified as clean or clean-contaminated are the intended participants.
Not a fit: Patients having contaminated or dirty procedures, those requiring or creating a stoma, emergency surgeries, or operations outside the listed procedures are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, it could allow earlier dressing removal, improving comfort and simplifying care without increasing infection risk.
How similar studies have performed: Smaller studies and a Cochrane review have suggested that early dressing removal does not increase superficial SSI rates, but the existing evidence is limited and low in quality.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient of legal age (≥18 years) * Scheduled for elective abdominal surgery requiring a skin incision of at least 4 cm long listed below: All pancreatectomies, All hepatectomies, All splenectomies, All adrenalectomies, All bariatric surgeries, All gastric surgeries, including gastrectomy and reflux surgery, All parietal surgeries; ventral hernia repairs, inguinal or femoral hernia repairs, with or without mesh placement.. All small bowel resections, Laparotomy cholecystectomies, All duodenal surgeries, Right, transverse or left colectomy, by laparotomy or laparoscopy, provided that there is a skin incision for extraction of the surgical specimen, but without the presence or creation of a stoma Proctectomy but without the presence or creation of a stoma * Class I or II (clean or clean-contaminated) according to the ALTEMEIER classification * Affiliated in a Social Security scheme (beneficiary or entitled person, excluding AME) * Have signed an informed consent form Exclusion Criteria: * Presence or completion of a stoma * Previous abdominal surgery in the month prior to inclusion * Emergency surgery * Outpatient surgery * Closure by biological glue * Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery) * Neutrophil count \< 500/mm3 at time of surgery * Grade B or C cirrhosis (Child-Pugh classification) * Pregnancy * Breast-feeding * Patient under guardianship or curatorship * Patient deprived of liberty by judicial or administrative decision * Patient unable to perform perioperative care
Where this trial is running
Paris
- Hôpital de la Pitié-Salpêtriere - APHP — Paris, France (Recruiting)
Study contacts
- Study coordinator: Sebastien GAUJOUX, Prof
- Email: sebastien.gaujoux@aphp.fr
- Phone: 0184827972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.