Adhesive Tape in Episiotomy Repair

Episiotomy Clinical Trial

Official title:

SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608671
• Other study ID #: Adhesive tape&episiotomy
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

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 increase in pain and dyspareunia during the puerperium

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primiparous.

• First and second degree perineal tear.

• Normal not instrumental vaginal delivery; spontaneous not induced.

• Patient willingness to randomize to episiotomy repair technique.

Exclusion Criteria:

• Previously existing local infections or lesions.

• Third and forth degrees perineal tear.

• Maternal diseases interfere with wound healing or causing excessive bleeding (coagulopathy, collagen disease, diabetes mellitus, known immunodeficiency, immunosuppressive treatment).

• Known hypersensitivity to adhesive materials

• Maternal unwillingness to undergo randomization.

• Participation in another intervention-trial with interference of intervention and/or outcome of this study.

Related Conditions & MeSH terms

• Episiotomy

Intervention

Procedure:
• Skin adhesive tape

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Ain Shams University	Dr. Ahmed Sherif, Dr. Mohamed Mahmoud El Sherbiny, Dr.Haitham Torky, Lobna Ahmed Nabil, Prof. Mohamed Ashraf Mohamed Farouk Kortam

References & Publications (2)

Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26. — View Citation

Ghosh A, Nanjappa M, Nagaraj V, Rajkumar GC. Comparison between stainless steel staples and silk sutures for primary closure of skin in patients undergoing neck dissection: A comparative clinical study. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S51-5. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	pain experience will be evaluated during the procedure,, 6 hours and 12 hours after the procedure by Wong-Baker faces pain rating scale .; During the second visit 7-10 days after delivery; pain and patient satisfaction will be evaluated and recorded, data may be collected by phone for those may not be able to come back for the second visit.	During 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 phone for those may not be able to come back for the second visit.	10 days
Secondary	wound sepsis	During the second visit 7-10 days after delivery; wound sepsis will be evaluated and recorded by wound sepsis score, data may be collected by phone for those may not be able to come back for the second visit.	10 days
Secondary	Postoperative pain	pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .	2 hours after procedure
Secondary	Postoperative pain	pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .	6 hours after procedure
Secondary	Postoperative pain	pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .	12 hours after procedure
Secondary	Postoperative pain	pain experience will be evaluated by Wong-Baker faces pain rating scale .	10 days after procedure
Secondary	timing of procedure	timing of both procedures will be recorded and documented	During the procedure