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RecruitingNCT06569862

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
1,288 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREPostoperative day 1 dressingThe patient's dressing will be removed on the first day after surgery, leaving the incision exposed to air, with daily cleaning.
PROCEDUREPostoperative day 6+/-1 dressingThe 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.

Timeline

Start date
2025-11-06
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2024-08-26
Last updated
2026-01-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06569862. Inclusion in this directory is not an endorsement.