Effect of Triclosan-coated Suture on Superficial SSI

December 20, 2013 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • General University Hospital Elche

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:

  • Fecal peritonitis

Exclusion Criteria:

  • Perioperative mortality

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triclosan
Suture of the abdominal wall with triclosan coated suture
Procedure: Triclosan coated suture
Suture of the abdominal wall with triclosan coated suture
Sham Comparator: No triclosan
Suture of the abdominal wall with the same suture, but without triclosan
Procedure: No triclosan
Suture of the abdominal wall with suture without triclosan coat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial surgical site infection (SSI)
Time Frame: 60 postoperative days
SSI will be evaluated in the postoperative course and up to 60 days after surgery
60 postoperative days

Collaborators and Investigators

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

Sponsor

Hospital General Universitario Elche

Investigators

  • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario de Elche

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

October 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0010

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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