Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Ain Shams University207 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Episiotomy

Interventions

subcuticular suturingPROCEDURE

Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).

Surgical gluePROCEDURE

Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).

adhesive steri-strip tapePROCEDURE

Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 10 days postnatal

Data from ClinicalTrials.gov

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