NCT02608671

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

November 9, 2015

Last Update Submit

January 16, 2021

Conditions

Episiotomy

Keywords

Episiotomycontinuous sutureSkin adhesive tape

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • wound healing.

    10 days

  • wound sepsis

    10 days

  • Postoperative pain

    2 hours after procedure

  • Postoperative pain

    6 hours after procedure

  • Postoperative pain

    12 hours after procedure

  • +2 more secondary outcomes

Study Arms (2)

Continuous skin suturing

NO INTERVENTION

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

Adhesive tape

EXPERIMENTAL

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

Procedure: Skin adhesive tape

Interventions

Skin adhesive tapePROCEDURE
Also known as: (® Steri-Strip
Adhesive tape

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous.
  • First and second degree perineal tear.
  • Normal not instrumental vaginal delivery; spontaneous not induced.
  • Patient willingness to randomize to episiotomy repair technique.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 25089271RESULT

  • 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.

    PMID: 25821376RESULT

MeSH Terms

Interventions

Surgical Tape

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

January 20, 2021

Record last verified: 2021-01