Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Episiotomy

Treatments: Procedure: adhesive steri-strip tape; Procedure: subcuticular suturing; Procedure: Surgical glue

Study type: Interventional

Funder types: Other

Identifiers

NCT03780530

Ain shams maternity U

Details and patient eligibility

About

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

Enrollment: 207 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 3 patient groups

subcuticular suturing

Active Comparator group

Treatment:

Procedure: subcuticular suturing

surgical glue

Active Comparator group

Treatment:

Procedure: Surgical glue

adhesive steri-strip tape

Active Comparator group

Treatment:

Procedure: adhesive steri-strip tape