Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068517
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-09-27
Brief Title:
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CISSI
Brief Summary:
Surgical site infections SSI are a frequent complication in abdominal surgery SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs Closed incision negative pressure wound therapy ciNPWT consists of a non-invasive vacuum-assisted system that applies negative pressure to closed surgical incisions It is currently unclear if ciNPWT reduces SSI in patients undergoing abdominal surgery This trial will investigate the effect of ciNPWT on SSI in abdominal surgery
Detailed Description:
Background
Surgical site infections SSI are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality longer hospital stay and significantly increased healthcare costs Closed incision negative pressure wound therapy ciNPWT is a non-invasive vacuum-assisted system that applies negative pressure to closed surgical incisions Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery However based on the available randomized controlled trials RCT the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient
Rationale
Considering the frequent occurrence of SSI in abdominal surgery associated worse outcomes and insufficient evidence an adequately powered robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted Provided that ciNPWT significantly reduces the incidence of SSI this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery
Aim of the trial
To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy
Methodology
Multicenter open-label two arm parallel group RCT Patients undergoing elective or emergency laparotomy will be enrolled During surgery participants will be randomized in a 11 ratio to the ciNPWT treatment or standard dressing control group After the completion of abdominal surgery and standardized skin closure with staples either ciNPWT or standard dry dressings will be applied Other than the study procedure participants in both groups will be treated the same according to the current standard of care at the participating centers Data collection will be carried out during the subsequent hospital stay and at 30 - 7 days postoperatively
Hypothesis
The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy
Surgical site infections SSI are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality longer hospital stay and significantly increased healthcare costs Closed incision negative pressure wound therapy ciNPWT is a non-invasive vacuum-assisted system that applies negative pressure to closed surgical incisions Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery However based on the available randomized controlled trials RCT the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient
Rationale
Considering the frequent occurrence of SSI in abdominal surgery associated worse outcomes and insufficient evidence an adequately powered robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted Provided that ciNPWT significantly reduces the incidence of SSI this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery
Aim of the trial
To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy
Methodology
Multicenter open-label two arm parallel group RCT Patients undergoing elective or emergency laparotomy will be enrolled During surgery participants will be randomized in a 11 ratio to the ciNPWT treatment or standard dressing control group After the completion of abdominal surgery and standardized skin closure with staples either ciNPWT or standard dry dressings will be applied Other than the study procedure participants in both groups will be treated the same according to the current standard of care at the participating centers Data collection will be carried out during the subsequent hospital stay and at 30 - 7 days postoperatively
Hypothesis
The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None