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Completed

NCT Number: NCT03702751

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

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..

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Ashour

Giza, 12944, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adhesive tape

Procedure

will be subjected to skin repair after episiotomy with skin adhesive tape.

Continuous subcuticular skin suturing

Procedure

will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.

Primary outcomes

  1. Severity of pain 6h postoperatively

    Time frame: 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

    Time frame: 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 outcomes

  1. wound healing

    Time frame: 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

    Time frame: 10 days after procedure

    pain experience will be evaluated by visual analog scale

  3. timing of procedure

    Time frame: During the procedure

    timing of both procedures will be recorded and documented

  4. Severity of pain immediately after episiotomy repair

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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