Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery
Primary Purpose
Surgical Site Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mupirocin ointment
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infections focused on measuring Colorectal Surgery
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Elective Colorectal surgery
- Open and minimally invasive cases
- Partial and total Colon resections, Abdominoperineal resection, Low anterior resections, Creation/takedown of colostomy, abdominal procedures for prolapse
Exclusion Criteria:
- Patients with known allergies to mupirocin
- Cases in which the skin was intentionally left open at the end of surgery (secondary closure technique)
- Women who are pregnant or planning to become pregnant
Sites / Locations
- Gundersen Lutheran Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mupirocin dressing
Island dressing
Arm Description
Mupirocin + island dressing applied to surgical incision until postoperative day 5. Intervention: mupirocin ointment applied to extrication incision.
Island dressing applied to surgical incision until postoperative day 2. This arm will not undergo any intervention.
Outcomes
Primary Outcome Measures
Surgical Site Infection
Surgical site infection defined per ACS NSQIP criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT02619773
First Posted
November 30, 2015
Last Updated
January 4, 2019
Sponsor
Gundersen Lutheran Medical Foundation
Collaborators
Gundersen Lutheran Health System
1. Study Identification
Unique Protocol Identification Number
NCT02619773
Brief Title
Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery
Official Title
The Use of Mupirocin Dressings and Its Effect on Surgical Site Infections in Elective Colorectal Surgery: A Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gundersen Lutheran Medical Foundation
Collaborators
Gundersen Lutheran Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infections at the site of surgical incisions (SSIs) are the most common infection among surgical patients. Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from 3-45%. These infections can increase the length of hospital stay, and increase the rate of readmissions and costs.
Further research is needed to study the effects of mupirocin in general surgery. A recent study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze dressings. However, these studies have not been performed in the United States and have only been studied on a very specific patient population.
The purpose of this study is to assess the rate of infections at the surgical incision after colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing without mupirocin.
Detailed Description
Surgical site infections (SSIs) are the most common nosocomial infection among surgical patients and are the third most common nosocomial infection among all hospitalized patients.1 Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has consistently had high rates of surgical site infections, ranging from 3-45%. Numerous studies have shown the adverse effects of SSIs, including increased length of hospital stay, morbidity, mortality, readmissions and costs. In a recent study analyzing various surgical procedures, including colorectal operations, surgical site infection was found to be the number one cause of unplanned readmission.
Studies have been performed showing that intranasal mupirocin may have a role in reduction of SSI in cardiac and orthopedic surgery. However, there has been minimal investigation on the effects of topical mupirocin in general surgery. A recent study from Spain compared colorectal SSI rates between mupirocin dressings, silver-impregnated dressings, and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze and silver-impregnated dressings. However, these studies have not been performed in the United States and have only been studied on open, colorectal oncologic surgery.
The aim of this study is to compare mupirocin dressings to standard surgical dressings and their respective SSI rates at a United States community hospital in patients undergoing elective open and minimally invasive colorectal surgery.
A single-center prospective, randomized study will be performed. Patients who will undergo elective colorectal surgery and consent to participate will be randomized (1:1) to one of the following 2 treatment groups:
Island dressings until postoperative day (POD) #2 (which is current practice at Gundersen Health System)
Mupirocin + island dressing until POD#5 Analysis of outcomes will include rate of SSI, and 30-day morbidity and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
Colorectal Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mupirocin dressing
Arm Type
Experimental
Arm Description
Mupirocin + island dressing applied to surgical incision until postoperative day 5.
Intervention: mupirocin ointment applied to extrication incision.
Arm Title
Island dressing
Arm Type
No Intervention
Arm Description
Island dressing applied to surgical incision until postoperative day 2. This arm will not undergo any intervention.
Intervention Type
Procedure
Intervention Name(s)
mupirocin ointment
Intervention Description
Mupirocin ointment will be applied after skin closure. A standard island dressing will be placed over the incision.
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
Surgical site infection defined per ACS NSQIP criteria
Time Frame
within 30 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Elective Colorectal surgery
Open and minimally invasive cases
Partial and total Colon resections, Abdominoperineal resection, Low anterior resections, Creation/takedown of colostomy, abdominal procedures for prolapse
Exclusion Criteria:
Patients with known allergies to mupirocin
Cases in which the skin was intentionally left open at the end of surgery (secondary closure technique)
Women who are pregnant or planning to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Shapiro, MD
Organizational Affiliation
Gundersen Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gundersen Lutheran Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery
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