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

Episiotomy Wound Clinical Trial

Official title:

Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702751
• Other study ID #: episiotomy
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Episiotomy Wound

Intervention

Procedure:
• Adhesive tape
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.

Locations

Country	Name	City	State
Egypt	Ahmed Ashour	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	wound healing	During the second visit 7-10 days after delivery; wound healing will be evaluated and recorded by Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA), data may be collected by home visits for those may not be able to come back for the second visit.	7-10 days after delivery
Secondary	Severity of pain 10 days postpartum	pain experience will be evaluated by visual analog scale	10 days after procedure
Secondary	timing of procedure	timing of both procedures will be recorded and documented	During the procedure
Secondary	Severity of pain immediately after episiotomy repair	pain experience will be evaluated immediately after the procedure by the visual analog scale(VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.	immediately after the procedure