Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 2:52 PM
Study NCT ID:
NCT02007018
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Status:
COMPLETED
Status Verified Date:
2018-10
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:
NEPTUNE
Brief Summary:
The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.
Detailed Description:
The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: