Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

October 16, 2014 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.
  • Open surgical approach

Exclusion Criteria:

  • Anastomotic leak
  • Mortality
  • Lost to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ionic silver-containing dressing
After placing the staples, a ionic silver-containing dressing was placed covering the wound.
Procedure: ionic silver-containing dressing
After placing the staples, a ionic silver-containing dressing was placed covering the wound
Experimental: Mupirocin ointment application
After placing the staples, a Mupirocin ointment application was placed covering the wound.
Procedure: Mupirocin ointment application
After placing the staples, Mupirocin ointment application over the wound was performed
No Intervention: Conventional dressing
After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incisional Surgical site infection
Time Frame: 30 postoperative days
30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital General Elche

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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