Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery

Sponsor
Gundersen Lutheran Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT02619773
Collaborator
Gundersen Lutheran Health System (Other)
150
1
2
37
4.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: mupirocin ointment
N/A

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:

  1. Island dressings until postoperative day (POD) #2 (which is current practice at Gundersen Health System)

  2. Mupirocin + island dressing until POD#5 Analysis of outcomes will include rate of SSI, and 30-day morbidity and mortality.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Use of Mupirocin Dressings and Its Effect on Surgical Site Infections in Elective Colorectal Surgery: A Prospective, Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mupirocin dressing

Mupirocin + island dressing applied to surgical incision until postoperative day 5. Intervention: mupirocin ointment applied to extrication incision.

Procedure: mupirocin ointment
Mupirocin ointment will be applied after skin closure. A standard island dressing will be placed over the incision.

No Intervention: Island dressing

Island dressing applied to surgical incision until postoperative day 2. This arm will not undergo any intervention.

Outcome Measures

Primary Outcome Measures

  1. Surgical Site Infection [within 30 days postoperative]

    Surgical site infection defined per ACS NSQIP criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gundersen Lutheran Health System La Crosse Wisconsin United States 54601

Sponsors and Collaborators

  • Gundersen Lutheran Medical Foundation
  • Gundersen Lutheran Health System

Investigators

  • Principal Investigator: Stephen B Shapiro, MD, Gundersen Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kara Kallies, Academic Researcher, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT02619773
Other Study ID Numbers:
  • 2-15-10-001
First Posted:
Dec 2, 2015
Last Update Posted:
Jan 8, 2019
Last Verified:
Jan 1, 2019
Keywords provided by Kara Kallies, Academic Researcher, Gundersen Lutheran Medical Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2019