Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women

NCT03702751 | Completed

• 1 other identifier: episiotomy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be done to question the superiority of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women..

Conditions

Episiotomy Wound

Outcome Measures

Primary Outcomes (2)

• Severity of pain 6h postoperatively

  the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.

  6 hours after the procedure

• Severity of pain 12 hours postpartum

  the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.

  12 hours after the procedure

Secondary Outcomes (4)

• wound healing

  7-10 days after delivery

• Severity of pain 10 days postpartum

  10 days after procedure

• timing of procedure

  During the procedure

• Severity of pain immediately after episiotomy repair

  immediately after the procedure

Study Arms (2)

Adhesive tape

EXPERIMENTAL

will be subjected to skin repair after episiotomy with skin adhesive tape.

Procedure: Adhesive tape

Continuous subcuticular skin suturing

ACTIVE COMPARATOR

will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.

Procedure: Continuous subcuticular skin suturing

Interventions

Adhesive tape PROCEDURE

will be subjected to skin repair after episiotomy with skin adhesive tape.

Adhesive tape

Continuous subcuticular skin suturing PROCEDURE

will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.

Continuous subcuticular skin suturing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primigravidae 18 years or older.
• Spontaneous not induced full term normal not instrumental vaginal delivery with mediolateral episiotomy.
• First and 2nd-degree perineal tear.
• BMI≥30

You may not qualify if:

• patients who had an instrumental delivery.
• rd and fourth-degree perineal tears.
• those with local infectious lesions in the area to be repaired.
• preexisting medical disorders as diabetes mellitus, severe pulmonary disease and collagen disease.
• Immunosuppressive treatment.
• known hypersensitivity to adhesive tape or materials.
• Maternal unwillingness to undergo randomization.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Ashour

Giza, 12944, Egypt

Location

MeSH Terms

Interventions

Surgical Tape

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 11, 2018
• Study Start: October 25, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 30, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

EG (1)