Efficacy of Triclosan-coated Sutures in the Episiotomy (EPISIOVIC)

July 27, 2016 updated by: Amira Ayachi, University Tunis El Manar

The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial

Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).

Data were analyzed according to the intention to treat principle.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

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

  • Tunisia
      • Bizerte, Tunisia, 7000
        • Recruiting
        • University Hospital Bougatfa
        • Contact:

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

Female

Description

Inclusion Criteria:

  • Pregnant women who had had an episiotomy at the delivery
  • vaginal delivery
  • no further perineal or vaginal lesions present

Exclusion Criteria:

  • collagen disease
  • known immunodeficiency
  • Clinical signs of infection at the time of episiotomy
  • History of keloids and a medical disorder that could affect wound healing
  • Hypersensitivity to any of the suture materials used in the protocol
  • Diabetes mellitus
  • Disorders requiring chronic corticosteroid use or immunosuppression
  • Instrumental extraction

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VICRYL PLUS
triclosan-coated sutures
Procedure: vicryl plus suture
episiotomy with triclosan-coated sutures
Active Comparator: VICRYL
non antibacterial coated sutures
Procedure: vicryl suture
episiotomy with non antibacterial coated suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of sutures used
Time Frame: two hours
two hours
number of patients with wound complications (infection, hematoma, disruption)
Time Frame: one week
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost of the treatment with and without infection
Time Frame: two weeks
cost of the treatment with and without infection
two weeks
number of patients with adverse outcomes
Time Frame: two weeks
two weeks

Collaborators and Investigators

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

Sponsor

University Tunis El Manar

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

July 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • episio1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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