Hôpital de la Pitié-Salpêtriere - APHP
Paris, 75013, France
Location status: Recruiting
NCT Number: NCT06569862
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
The patient's dressing will be removed on the first day after surgery, leaving the incision exposed to air, with daily cleaning.
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.
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).
Time frame: Day 30 post-surgery
Medical-economic impact
Time frame: 30 days post-surgery
Time frame: 30 days post-surgery
Time frame: 30 days post-surgery
Time frame: 30 days post-surgery
Time frame: 30 days post-surgery
Time frame: 30 days post-surgery
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Sebastien GAUJOUX, Prof
CONTACT
Stéphanie LE BOT, Mme
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
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
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.
NCT07451015
Diabetes Mellitus, Diabetes Mellitus, Type 2
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT05486962
Elective Abdominal Surgery
Durham, North Carolina, United States
View Trial DetailsNCT07735962
Gynecologic Cancers, Infections
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07379684
Infections, Pathologic Processes
Torrance, California, United States
View Trial Details