Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Pitié-Salpêtriere - APHP

Paris, 75013, France

Location status: Recruiting

Location contact

Sébastien Gaujoux, Pr

CONTACT

[email protected]

0184827972

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative day 1 dressing

Procedure

The patient's dressing will be removed on the first day after surgery, leaving the incision exposed to air, with daily cleaning.

Postoperative day 6+/-1 dressing

Procedure

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 outcomes

  1. Proportion of superficial surgical site infections (SSI)

    Time frame: 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 outcomes

  1. Direct and indirect costs

    Time frame: Day 30 post-surgery

    Medical-economic impact

  2. Rate of repeat surgery

    Time frame: 30 days post-surgery

  3. Rate of unscheduled nursing care

    Time frame: 30 days post-surgery

  4. Percentage of patients who asked for their scars to be covered

    Time frame: 30 days post-surgery

  5. Total length of hospital stay

    Time frame: 30 days post-surgery

  6. Overall morbidity rate according to Clavien-Dindo

    Time frame: 30 days post-surgery

  7. Rate of antibiotic treatment

    Time frame: 30 days post-surgery

  8. Quality of life for patients

    Time frame: Day 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).

  9. The incremental cost-effectiveness ratio (ICER)

    Time frame: 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.

  10. The incremental cost-utility ratio (ICUR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastien GAUJOUX, Prof

CONTACT

[email protected]

0184827972

Stéphanie LE BOT, Mme

CONTACT

[email protected]

0184827450

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PAN-STOP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.