Clinical trial NCT02608671: Adhesive Tape in Episiotomy Repair
Official title: SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Episiotomy
Keywords: Episiotomy
continuous suture
Skin adhesive tape
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Lobna Ahmed Nabil
name: Dr. Ahmed Sherif
name: Dr. Mohamed Mahmoud El Sherbiny
name: Prof. Mohamed Ashraf Mohamed Farouk Kortam
name: Dr.Haitham Torky
First posted: 2015-11-20
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative pain
timeFrame: During the procedure
Secondary outcomes:
measure: wound healing.
timeFrame: 10 days
measure: wound sepsis
timeFrame: 10 days
measure: Postoperative pain
timeFrame: 2 hours after procedure
measure: Postoperative pain
timeFrame: 6 hours after procedure
measure: Postoperative pain
timeFrame: 12 hours after procedure
measure: Postoperative pain
timeFrame: 10 days after procedure
measure: timing of procedure
timeFrame: During the procedure
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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: 10.4103/0976-237X.152938.