Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women

Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial

This study will be done to question the superiority of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women..

Study Overview

• Status: Completed
• Conditions: Episiotomy Wound
• Intervention / Treatment: Procedure: Adhesive tape; Procedure: Continuous subcuticular skin suturing

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 an increase in pain and dyspareunia during the puerperium

This study will be commenced to question the advantage of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12944
    • Ahmed Ashour

Participation Criteria

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:

• primigravidae 18 years or older.
• Spontaneous not induced full term normal not instrumental vaginal delivery with mediolateral episiotomy.
• First and 2nd-degree perineal tear.
• BMI≥30

Exclusion Criteria:

• • patients who had an instrumental delivery.

  • 3rd and fourth-degree perineal tears.
  • those with local infectious lesions in the area to be repaired.
  • preexisting medical disorders as diabetes mellitus, severe pulmonary disease and collagen disease.
  • Immunosuppressive treatment.
  • known hypersensitivity to adhesive tape or materials.
  • Maternal unwillingness to undergo randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adhesive tape; will be subjected to skin repair after episiotomy with skin adhesive tape.	Procedure: Adhesive tape; will be subjected to skin repair after episiotomy with skin adhesive tape.
Active Comparator: Continuous subcuticular skin suturing; will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.	Procedure: Continuous subcuticular skin suturing; will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pain 6h postoperatively	the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.	6 hours after the procedure
Severity of pain 12 hours postpartum	the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.	12 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
timing of procedure	timing of both procedures will be recorded and documented	During the procedure
wound healing	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 home visits for those may not be able to come back for the second visit.	7-10 days after delivery
Severity of pain 10 days postpartum	pain experience will be evaluated by visual analog scale	10 days after procedure
Severity of pain immediately after episiotomy repair	pain experience will be evaluated immediately after the procedure by the visual analog scale(VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.	immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: October 6, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 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