Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Study Overview
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Brief Summary
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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

Official Title
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Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Conditions
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Episiotomy

Intervention / Treatment
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* Procedure: subcuticular suturing
* Procedure: Surgical glue
* Procedure: adhesive steri-strip tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged above 18 yrs. Primiparous. Undergoing spontaneous vaginal delivery of a single full-term fetus. Vertex presentation. Having mediolateral episiotomy. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: subcuticular suturing<br> | Procedure: subcuticular suturing<br>* Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).<br>|
| Active Comparator: surgical glue<br> | Procedure: Surgical glue<br>* Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).<br>|
| Active Comparator: adhesive steri-strip tape<br> | Procedure: adhesive steri-strip tape<br>* Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short -term postpartum pain | Post-operative perineal pain will be evaluated at 6 hrs 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 | six hours postpartum | 
| Short -term postpartum pain | 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 | 10 days postnatal |