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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative day 1 dressing, Postoperative day 6+/-1 dressing.
- Who it may be relevant to
- Registry conditions: Elective Abdominal Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure Postoperative day 1 dressing
The patient's dressing will be removed on the first day after surgery, leaving the incision exposed to air, with daily cleaning. - Procedure Postoperative day 6+/-1 dressing
The patient will have a daily dressing change according to the usual nursing procedures, including saline serum washing, until the sixth day (+/- 1 day) after surgery. This will be done while the patient is in hospital, or at home if discharged before the sixth day.
Primary outcome measures
- Proportion of superficial surgical site infections (SSI) [Time frame: Day 30 post-surgery]
Secondary outcome measures (10)
- Direct and indirect costs [Time frame: Day 30 post-surgery]
- Rate of repeat surgery [Time frame: 30 days post-surgery]
- Rate of unscheduled nursing care [Time frame: 30 days post-surgery]
- Percentage of patients who asked for their scars to be covered [Time frame: 30 days post-surgery]
- Total length of hospital stay [Time frame: 30 days post-surgery]
- Overall morbidity rate according to Clavien-Dindo [Time frame: 30 days post-surgery]
- Rate of antibiotic treatment [Time frame: 30 days post-surgery]
- Quality of life for patients [Time frame: Day 6 and Day 30 post-surgery]
- The incremental cost-effectiveness ratio (ICER) [Time frame: 30 days after inclusion]
- The incremental cost-utility ratio (ICUR) [Time frame: 30 days after inclusion]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpital de la Pitié-Salpêtriere - APHP — Paris
Identifiers
NCT: NCT06569862 · APHP230859