Clinical trial NCT03702751: Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women
Official title: Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 100
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 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..

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of pain 6h postoperatively
timeFrame: 6 hours after the procedure
measure: Severity of pain 12 hours postpartum
timeFrame: 12 hours after the procedure
Secondary outcomes:
measure: wound healing
timeFrame: 7-10 days after delivery
measure: Severity of pain 10 days postpartum
timeFrame: 10 days after procedure
measure: timing of procedure
timeFrame: During the procedure
measure: Severity of pain immediately after episiotomy repair
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Ashour
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: