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Recruiting Not applicable

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

NCT06569862 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-11-06
Last updated
2026-01-15

Condition(s) studied

Elective Abdominal Surgery

Investigational drug(s) / intervention(s)

Postoperative day 1 dressingPostoperative day 6+/-1 dressing

Postoperative day 1 dressing: The patient's dressing will be removed on the first day after surgery, leaving the incision exposed to air, with daily cleaning.

Postoperative day 6+/-1 dressing: The patient will have a daily dressing change according to the usual nursing procedures, including saline serum washing, until the sixth day (+/- 1 day) after surgery. This will be done while the patient is in hospital, or at home if discharged before the sixth day.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of superficial surgical site infections (SSI) — Day 30 post-surgery
    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).

Trial sites (1)

FacilityCityRegionStatus
Hôpital de la Pitié-Salpêtriere - APHP Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06569862 on ClinicalTrials.gov ↗ ← All trials in France