Biologic Glue for First Degree Perineal Tears

December 17, 2011 updated by: Ezra Yosi, Hadassah Medical Organization

Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

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

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears

Exclusion Criteria:

  • excessive bleeding,
  • chronic steroid treatment,
  • immunosuppressive treatment,
  • active infection,
  • allergy to Dermabond or Histoacryl

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
Experimental: 1
use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women
Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
adhesive of perineal tears
Active Comparator: 3
use of traditional suturing for perineal tear grade 1 in 50 women
Procedure: 3. traditional suturing with vicryl rapid 2X0
suturing of perineal tears grade one with vicryl rapid 2X0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional and cosmetic evaluation of perineal tear area.
Time Frame: At least six weeks after birth
At least six weeks after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of pain at least six weeks after delivery
Time Frame: At least six weeks after delivery
At least six weeks after delivery

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Investigators

  • Study Director: yosef ezra, M.D., hadassha medical organization, jerusalem israel

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

September 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 20, 2011

Last Update Submitted That Met QC Criteria

December 17, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • feigenberg HMO-CTIL

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.

Clinical Trials on Grade 1 Perineal Tears

Clinical Trials on 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe