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Adhesive Tape in Episiotomy Repair

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608671
Enrollment
320
Registered
2015-11-20
Start date
2015-12-31
Completion date
2017-12-01
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy

Keywords

Episiotomy, continuous suture, Skin adhesive tape

Brief 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.

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 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.

Interventions

PROCEDURESkin adhesive tape

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative painDuring the procedurepain 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.

Secondary

MeasureTime frameDescription
wound healing.10 daysDuring 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.
wound sepsis10 daysDuring 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.
Postoperative pain2 hours after procedurepain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .
timing of procedureDuring the proceduretiming of both procedures will be recorded and documented

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026