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

NCT02619773 | Completed

• 1 other identifier: 2-15-10-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infections

Keywords

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Surgical site infection defined per ACS NSQIP criteria

  within 30 days postoperative

Study Arms (2)

Mupirocin dressing

EXPERIMENTAL

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

Procedure: mupirocin ointment

Island dressing

NO INTERVENTION

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

Interventions

mupirocin ointment PROCEDURE

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

Mupirocin dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gundersen Lutheran Medical Foundation: lead
• Gundersen Lutheran Health System: collaborator

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen B Shapiro, MD

  Gundersen Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Researcher

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

US (1)