Adhesive Tape in Episiotomy Repair

Phase 4

Completed

• Conditions: Episiotomy
• Interventions: Procedure: Skin adhesive tape

• Registration Number: NCT02608671
• Lead Sponsor: Ain Shams University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2015-12
• Primary Completion: 2017-01-01
• Study Completion: 2017-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesive tape	Skin adhesive tape	will be subjected to skin repair after episiotomy with skin adhesive tape.

Primary Outcome Measures

Name	Time	Method
postoperative pain	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.

Secondary Outcome Measures

Name	Time	Method
timing of procedure	During the procedure	timing of both procedures will be recorded and documented
Postoperative pain	10 days after procedure	pain experience will be evaluated by Wong-Baker faces pain rating scale .
wound healing.	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.
wound sepsis	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.