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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

Not Applicable
Not yet recruiting
Conditions
Elective Abdominal Surgery
Interventions
Procedure: Postoperative day 1 dressing
Procedure: Postoperative day 6+/-1 dressing
Registration Number
NCT06569862
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1288
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Postoperative day 1 dressingPostoperative day 1 dressingAfter removing the dressing on day 1, no dressing change by a nurse is required.
Postoperative day 6+/-1 dressingPostoperative day 6+/-1 dressingDaily dressing changes should be performed according to standard nursing procedures until postoperative day 6 (+/-1)
Primary Outcome Measures
NameTimeMethod
Proportion of superficial surgical site infections (SSI)Day 30 post-surgery

The percentage of superficial surgical site infections (SSI) within the 30 days following surgery, defined according to the criteria set by the Centers for Disease Control and Prevention (CDC).

Secondary Outcome Measures
NameTimeMethod
Rate of antibiotic treatment30 days post-surgery
Rate of repeat surgery30 days post-surgery
Overall morbidity rate according to Clavien-Dindo30 days post-surgery
Rate of unscheduled nursing care30 days post-surgery
Percentage of patients who asked for their scars to be covered30 days post-surgery
The incremental cost-effectiveness ratio (ICER)30 days after inclusion

The incremental cost-effectiveness ratio (ICER) measures the costs (from the healthcare system perspective) per infection prevented between the intervention and control arms 30 days after inclusion. It is calculated as the difference in average costs between the two arms divided by the difference in average number of infections between them.

Direct and indirect costsDay 30 post-surgery

Medical-economic impact

Total length of hospital stay30 days post-surgery
Quality of life for patientsDay 6 and Day 30 post-surgery

Patient's quality of life on days 6 and 30 post-surgery as assessed using the EuroQol Research Foundation 5 Dimensions Self-Questionnaire (EQ-5D-5L).

The incremental cost-utility ratio (ICUR)30 days after inclusion

The incremental cost-utility ratio (ICUR) assesses the costs (from the healthcare system perspective) per Quality-Adjusted Life Year (QALY) gained between the intervention arm and the control arm 30 days after inclusion. Quality of life is evaluated using the EQ-5D-5L scale (EuroQol Group) at the inclusion visit, discharge from hospital, and at 30 days, covering five dimensions (mobility, stress/anxiety, ability to perform daily activities, autonomy, pain/discomfort). ICUR is calculated as the difference in average costs between the two arms divided by the difference in average QALYs gained between them.

Trial Locations

Locations (1)

Hôpital de la Pitié-Salpêtriere - APHP

🇫🇷

Paris, France

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