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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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06569862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Postoperative day 1 dressing
  • Postoperative day 6+/-1 dressing
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Where

1 site
Hôpital de la Pitié-Salpêtriere - APHP
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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