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 ID: NCT06569862

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Elective Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Postoperative day 1 dressing

After removing the dressing on day 1, no dressing change by a nurse is required.

Group Type: EXPERIMENTAL

Postoperative day 1 dressing

Intervention Type: PROCEDURE

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

Daily dressing changes should be performed according to standard nursing procedures until postoperative day 6 (+/-1)

Group Type: OTHER

Postoperative day 6+/-1 dressing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Pitié-Salpêtriere - APHP

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sebastien GAUJOUX, Prof

Role: CONTACT

sebastien.gaujoux@aphp.fr

0184827972

Stéphanie LE BOT, Mme

Role: CONTACT

stephanie.lebot@aphp.fr

0184827450

Facility Contacts

Sébastien Gaujoux, Pr

Role: primary

sebastien.gaujoux@aphp.fr

0184827972

Other Identifiers

APHP230859

Identifier Type: -

Identifier Source: org_study_id