Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Episiotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03780530
• Other study ID #: Ain shams maternity U
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Episiotomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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