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 (PAN-STOP)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Elective Abdominal Surgery

Treatments: Procedure: Postoperative day 1 dressing; Procedure: Postoperative day 6+/-1 dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06569862

APHP230859

Details and patient eligibility

About

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.

Enrollment: 1,288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Trocar holes
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,288 participants in 2 patient groups

Postoperative day 1 dressing

Experimental group

Description:

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

Treatment:

Procedure: Postoperative day 1 dressing

Postoperative day 6+/-1 dressing

Other group

Description:

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

Treatment:

Procedure: Postoperative day 6+/-1 dressing