Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Elective Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1288 Patients enrolled
Trial Details
Trial ID
NCT06569862
Start Date
October 1 2024
End Date
December 1 2026
Last Update
August 26 2024
Active Locations (1)
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1
Hôpital de la Pitié-Salpêtriere - APHP
Paris, France, 75013