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Completed

NCT Number: NCT00746707

Biologic Glue for First Degree Perineal Tears

The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair

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Key information

Conditions

Grade 1 Perineal Tears

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears

Exclusion criteria

  • excessive bleeding,
  • chronic steroid treatment,
  • immunosuppressive treatment,
  • active infection,
  • allergy to Dermabond or Histoacryl

Treatment and study plan

1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

Device

adhesive of perineal tears

3. traditional suturing with vicryl rapid 2X0

Procedure

suturing of perineal tears grade one with vicryl rapid 2X0

Primary outcomes

  1. Functional and cosmetic evaluation of perineal tear area.

    Time frame: At least six weeks after birth

Secondary outcomes

  1. Assessment of pain at least six weeks after delivery

    Time frame: At least six weeks after delivery

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 4, 2008
Registry last updated
Dec 20, 2011

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.