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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative day 1 dressing | Experimental | After removing the dressing on day 1, no dressing change by a nurse is required. |
|
| Postoperative day 6+/-1 dressing | Other | Daily dressing changes should be performed according to standard nursing procedures until postoperative day 6 (+/-1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 30 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Direct and indirect costs | Medical-economic impact | Day 30 post-surgery |
| Rate of repeat surgery | 30 days post-surgery | |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastien GAUJOUX, Prof | Contact | 0184827972 | sebastien.gaujoux@aphp.fr | |
| Stéphanie LE BOT, Mme | Contact | 0184827450 | stephanie.lebot@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Pitié-Salpêtriere - APHP | Recruiting | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| 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. |
|
| Rate of unscheduled nursing care |
| 30 days post-surgery |
| Percentage of patients who asked for their scars to be covered | 30 days post-surgery |
| Total length of hospital stay | 30 days post-surgery |
| Overall morbidity rate according to Clavien-Dindo | 30 days post-surgery |
| Rate of antibiotic treatment | 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). | 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. | 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. | 30 days after inclusion |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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