Clinical trial NCT06569862: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elective Abdominal Surgery
Keywords: Surgical site infection
Dressing
Elective abdominal surgery
Postoperative care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 1288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of superficial surgical site infections (SSI)
timeFrame: Day 30 post-surgery
Secondary outcomes:
measure: Direct and indirect costs
timeFrame: Day 30 post-surgery
measure: Rate of repeat surgery
timeFrame: 30 days post-surgery
measure: Rate of unscheduled nursing care
timeFrame: 30 days post-surgery
measure: Percentage of patients who asked for their scars to be covered
timeFrame: 30 days post-surgery
measure: Total length of hospital stay
timeFrame: 30 days post-surgery
measure: Overall morbidity rate according to Clavien-Dindo
timeFrame: 30 days post-surgery
measure: Rate of antibiotic treatment
timeFrame: 30 days post-surgery
measure: Quality of life for patients
timeFrame: Day 6 and Day 30 post-surgery
measure: The incremental cost-effectiveness ratio (ICER)
timeFrame: 30 days after inclusion
measure: The incremental cost-utility ratio (ICUR)
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtriere - APHP
Study officials:
References: