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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Proportion of superficial surgical site infections (SSI) [Срок оценки: Day 30 post-surgery]

Вторичные конечные точки (10)

• Direct and indirect costs [Срок оценки: Day 30 post-surgery]
• Rate of repeat surgery [Срок оценки: 30 days post-surgery]
• Rate of unscheduled nursing care [Срок оценки: 30 days post-surgery]
• Percentage of patients who asked for their scars to be covered [Срок оценки: 30 days post-surgery]
• Total length of hospital stay [Срок оценки: 30 days post-surgery]
• Overall morbidity rate according to Clavien-Dindo [Срок оценки: 30 days post-surgery]
• Rate of antibiotic treatment [Срок оценки: 30 days post-surgery]
• Quality of life for patients [Срок оценки: Day 6 and Day 30 post-surgery]
• The incremental cost-effectiveness ratio (ICER) [Срок оценки: 30 days after inclusion]
• The incremental cost-utility ratio (ICUR) [Срок оценки: 30 days after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital de la Pitié-Salpêtriere - APHP — Paris

Идентификаторы

NCT: NCT06569862 · APHP230859

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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