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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03702751
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.1
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Episiotomy Wound	Procedure: Adhesive tape; Procedure: Continuous subcuticular skin suturing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial
• Actual Study Start Date: Oct 25, 2018
• Actual Primary Completion Date: Mar 10, 2021
• Actual Study Completion Date: Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adhesive tape will be subjected to skin repair after episiotomy with skin adhesive tape.	Procedure: Adhesive tape; will be subjected to skin repair after episiotomy with skin adhesive tape.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Severity of pain 6h postoperatively [6 hours after the procedure]

   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.

2. Severity of pain 12 hours postpartum [12 hours after the procedure]

   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.

Secondary Outcome Measures

1. wound healing [7-10 days after delivery]

   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.

2. Severity of pain 10 days postpartum [10 days after procedure]

   pain experience will be evaluated by visual analog scale

3. timing of procedure [During the procedure]

   timing of both procedures will be recorded and documented

4. Severity of pain immediately after episiotomy repair [immediately after the procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Ashour	Giza		Egypt	12944

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: AHMED SAMY, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
• ClinicalTrials.gov Identifier: NCT03702751
• Other Study ID Numbers: episiotomy
• First Posted: Oct 11, 2018
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 3, 2022