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Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Surgical Site Infections

Intervention: Negative Pressure Wound Therapy (Device); Usual Care of Surgical Wound (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Michael Ott, MD, MSc, FRCSC, FACS, FASCRS, Principal Investigator, Affiliation: Division of General Surgery, Western University

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.

Clinical Details

Official title: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Postoperative Surgical Site Infection (SSI)

Secondary outcome:

Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)

Length of Stay in Hospital

Cost of Management of Surgical Site Infection (SSI)

Number of Return Visits Related to Surgical Site Infection

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 18 years

- Planned elective colorectal resection (those that occur as a scheduled operation in

the surgeons' planned operative list) Exclusion Criteria:

- Palliative colorectal resection where predicted remaining lifespan is likely less

than 30 days

- Abdominoperineal resection or pelvic exenteration

- Known allergy/sensitivity to adhesive

- Cases in which there is a suspicion of bowel perforation

- Pregnancy

Locations and Contacts

London Health Sciences Centre - University Campus, London, Ontario N6A 5A5, Canada; Not yet recruiting

London Health Sciences Centre - Victoria Campus, London, Ontario N6A 5W9, Canada; Not yet recruiting

Additional Information

Starting date: September 2014
Last updated: December 9, 2013

Page last updated: August 20, 2015

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