Elective Abdominal SurgeryPAN-STOPNCT06569862
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 study testing Postoperative day 1 dressing and Postoperative day 6+/-1 dressing in people with Elective Abdominal Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Abdominal Surgery
- What is being tested?
- Postoperative day 1 dressing and Postoperative day 6+/-1 dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,288 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2025to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Pitié-Salpêtriere - APHP
Paris, 75013
Sébastien Gaujoux, Pr, 0184827972, sebastien.gaujoux@aphp.fr
About this study
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
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.
- Conditions
- Elective Abdominal Surgery
- Being tested
- Postoperative day 1 dressing, Postoperative day 6+/-1 dressing
- Keywords
- Surgical site infection, Dressing, Elective abdominal surgery, Postoperative care
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative day 1 dressingProcedure or surgery
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 dressingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative day 1 dressing | Experimental | After removing the dressing on day 1, no dressing change by a nurse is required. Receives: Procedure: Postoperative day 1 dressing |
| Postoperative day 6+/-1 dressing | Other | Daily dressing changes should be performed according to standard nursing procedures until postoperative day 6 (+/-1) Receives: Procedure: Postoperative day 6+/-1 dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of superficial surgical site infections (SSI)
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).
Measured: Day 30 post-surgery
Secondary outcomes (10)
Direct and indirect costs
Medical-economic impact
Measured: Day 30 post-surgery
Rate of repeat surgery
Measured: 30 days post-surgery
Rate of unscheduled nursing care
Measured: 30 days post-surgery
Percentage of patients who asked for their scars to be covered
Measured: 30 days post-surgery
Total length of hospital stay
Measured: 30 days post-surgery
Overall morbidity rate according to Clavien-Dindo
Measured: 30 days post-surgery
Rate of antibiotic treatment
Measured: 30 days post-surgery
Quality of life for patients
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).
Measured: Day 6 and Day 30 post-surgery
The incremental cost-effectiveness ratio (ICER)
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.
Measured: 30 days after inclusion
The incremental cost-utility ratio (ICUR)
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.
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start6 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569862
- Sponsor's protocol ID
- APHP230859
- Acronym
- PAN-STOP
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.