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

NCT ID: NCT03702751

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2021-03-30

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..

Detailed Description

Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents

The optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public

Apparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without an increase in pain and dyspareunia during the puerperium

This study will be commenced to question the advantage 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adhesive tape

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

Group Type: EXPERIMENTAL

Adhesive tape

Intervention Type: PROCEDURE

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

Continuous subcuticular skin suturing

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

Group Type: ACTIVE_COMPARATOR

Continuous subcuticular skin suturing

Intervention Type: PROCEDURE

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

Interventions

Adhesive tape

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

Intervention Type: PROCEDURE

Continuous subcuticular skin suturing

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • patients who had an instrumental delivery.

• 3rd 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ahmed Ashour

Giza, , Egypt

Countries

Egypt

Other Identifiers

episiotomy

Identifier Type: -

Identifier Source: org_study_id