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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Page 1 of 1 (1 locations)

1

Hôpital de la Pitié-Salpêtriere - APHP

Paris, France, 75013