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

Not Applicable

Completed

• Conditions: Episiotomy Wound
• Interventions: Procedure: Continuous subcuticular skin suturing; Procedure: Adhesive tape

• Registration Number: NCT03702751
• Lead Sponsor: Cairo University

Brief Summary

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..

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 Timeline

• Study First Submitted: 2018-10-06
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-11
• Study Start: 2018-10-25
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Severity of pain 6h postoperatively	6 hours after the procedure	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.
Severity of pain 12 hours postpartum	12 hours after the procedure	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.

Secondary Outcome Measures

Name	Time	Method
timing of procedure	During the procedure	timing of both procedures will be recorded and documented
wound healing	7-10 days after delivery	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.
Severity of pain 10 days postpartum	10 days after procedure	pain experience will be evaluated by visual analog scale
Severity of pain immediately after episiotomy repair	immediately after the procedure	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.

Trial Locations

Locations (1)

Ahmed Ashour; 🇪🇬 Giza, Egypt