Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03780530

Enrollment

207

Registered

2018-12-19

Start date

2019-01-01

Completion date

2019-12-01

Last updated

2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy

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

Interventions

PROCEDUREsubcuticular suturing

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

PROCEDURESurgical glue

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

PROCEDUREadhesive steri-strip tape

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Short -term postpartum pain	six hours postpartum	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026