Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Phase 3

• Conditions: Episiotomy
• Interventions: Procedure: adhesive steri-strip tape; Procedure: subcuticular suturing; Procedure: Surgical glue

• Registration Number: NCT03780530
• Lead Sponsor: Ain Shams University

Brief Summary

this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-20
• Study Start: 2019-01-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

• Women aged above 18 yrs.
• Primiparous.
• Undergoing spontaneous vaginal delivery of a single full-term fetus.
• Vertex presentation.
• Having mediolateral episiotomy.

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Exclusion Criteria

• Body mass index ≥ 35 kg/m2
• Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
• Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
• The use of epidural anesthesia.
• Previous perineal surgeries, local infection or lesions.
• Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
• Contraindication or Hypersensitivity to any of materials used in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adhesive steri-strip tape	adhesive steri-strip tape	-
subcuticular suturing	subcuticular suturing	-
surgical glue	Surgical glue	-

Primary Outcome Measures

Name	Time	Method
Short -term postpartum pain	10 days postnatal	Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain