Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

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

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 Overview

• Status: Unknown
• Conditions: Episiotomy
• Intervention / Treatment: Procedure: subcuticular suturing; Procedure: Surgical glue; Procedure: adhesive steri-strip tape

• Study Type: Interventional
• Enrollment (Anticipated): 207
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Ain shams maternity U

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No