Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

February 9, 2009 updated by: Hospital Sao Joao

Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.

Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Portugal
      • Porto, Portugal, 4200-319
        • Servico de Ginecologia e Obstetricia, Hospital de S, Joao

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • vaginal delivery
  • episiotomy performed
  • no further perineal or vaginal lesions present

Exclusion Criteria:

  • previously existing local infections or lesions
  • body mass index > 35 (Kg/m2)
  • severe pulmonary disease
  • collagen disease
  • known immunodeficiency
  • diabetes mellitus
  • immunosuppressive treatment

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Skin adhesive
perineal skin repair with octyl-2-cyanoacrylate skin adhesive
Procedure: octyl-2-cyanoacrylate adhesive glue
use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
Other Names:
  • Dermabond
ACTIVE_COMPARATOR: subcuticular suture
continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910
Procedure: Subcuticular suture of perineal skin
Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair
Other Names:
  • Vicryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-assessed perineal pain
Time Frame: First 30 days after delivery
First 30 days after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Total time spent with repair of episiotomy
Time Frame: within 1 hour after birth
within 1 hour after birth
Pain during procedure
Time Frame: within 1 hour after birth
within 1 hour after birth
Difficulties reported during procedure
Time Frame: within 1 hour after birth
within 1 hour after birth
Number of sutures and adhesive devices used
Time Frame: within 1 hour after birth
within 1 hour after birth
Wound complications
Time Frame: 42-68 hours after delivery
42-68 hours after delivery
Need to seek health facilities
Time Frame: 30 days after delivery
30 days after delivery
Return of sexual activity
Time Frame: 30 days after delivery
30 days after delivery

Collaborators and Investigators

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

Sponsor

Hospital Sao Joao

Collaborators

Universidade do Porto

Investigators

  • Principal Investigator: Diogo Ayres-de-Campos, PhD, Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto

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

May 1, 2005

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (ESTIMATE)

February 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Episio- 01 - RCT

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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