Elective Abdominal Surgery
Conditions
Keywords
Surgical site infection, Dressing, Elective abdominal surgery, Postoperative care
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.
Interventions
PROCEDUREPostoperative 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.
PROCEDUREPostoperative 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of repeat surgery | 30 days post-surgery | — |
| 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 | — |
| Direct and indirect costs | Day 30 post-surgery | Medical-economic impact |
| Rate of antibiotic treatment | 30 days post-surgery | — |
| Quality of life for patients | 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). |
| 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. |
| 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. |
| Overall morbidity rate according to Clavien-Dindo | 30 days post-surgery | — |
Countries
France
Contacts
Primary ContactSebastien GAUJOUX, Prof
Backup ContactStéphanie LE BOT, Mme
Outcome results
None listed