Adhesive Tape in Episiotomy Repair

January 16, 2021 updated by: Ahmed Abass, Ain Shams University

SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents

The optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public

Apparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without increase in pain and dyspareunia during the puerperium

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparous.
  • First and second degree perineal tear.
  • Normal not instrumental vaginal delivery; spontaneous not induced.
  • Patient willingness to randomize to episiotomy repair technique.

Exclusion Criteria:

  • Previously existing local infections or lesions.
  • Third and forth degrees perineal tear.
  • Maternal diseases interfere with wound healing or causing excessive bleeding (coagulopathy, collagen disease, diabetes mellitus, known immunodeficiency, immunosuppressive treatment).
  • Known hypersensitivity to adhesive materials
  • Maternal unwillingness to undergo randomization.
  • Participation in another intervention-trial with interference of intervention and/or outcome of this study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Continuous skin suturing
will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.
Experimental: Adhesive tape
will be subjected to skin repair after episiotomy with skin adhesive tape.
Procedure: Skin adhesive tape
Other Names:
  • (® Steri-Strip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: During the procedure

pain experience will be evaluated during the procedure,, 6 hours and 12 hours after the procedure by Wong-Baker faces pain rating scale .

During the second visit 7-10 days after delivery; pain and patient satisfaction will be evaluated and recorded, data may be collected by phone for those may not be able to come back for the second visit.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing.
Time Frame: 10 days
During the second visit 7-10 days after delivery; wound healing will be evaluated and recorded by Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA), data may be collected by phone for those may not be able to come back for the second visit.
10 days
wound sepsis
Time Frame: 10 days
During the second visit 7-10 days after delivery; wound sepsis will be evaluated and recorded by wound sepsis score, data may be collected by phone for those may not be able to come back for the second visit.
10 days
Postoperative pain
Time Frame: 2 hours after procedure
pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .
2 hours after procedure
Postoperative pain
Time Frame: 6 hours after procedure
pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .
6 hours after procedure
Postoperative pain
Time Frame: 12 hours after procedure
pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .
12 hours after procedure
Postoperative pain
Time Frame: 10 days after procedure
pain experience will be evaluated by Wong-Baker faces pain rating scale .
10 days after procedure
timing of procedure
Time Frame: During the procedure
timing of both procedures will be recorded and documented
During the procedure

Collaborators and Investigators

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

Sponsor

Ain Shams University

Collaborators

Lobna Ahmed Nabil
Dr. Ahmed Sherif
Dr. Mohamed Mahmoud El Sherbiny
Prof. Mohamed Ashraf Mohamed Farouk Kortam
Dr.Haitham Torky

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 (Actual)

December 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Adhesive tape&episiotomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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