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Biologic Glue for First Degree Perineal Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ezra Yosi, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00746707
First received: September 3, 2008
Last updated: December 17, 2011
Last verified: December 2011

September 3, 2008
December 17, 2011
September 2008
June 2011   (final data collection date for primary outcome measure)
Functional and cosmetic evaluation of perineal tear area. [ Time Frame: At least six weeks after birth ] [ Designated as safety issue: No ]
functional and cosmetic evaluation of perineal tear area. [ Time Frame: six weeks after birth ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00746707 on ClinicalTrials.gov Archive Site
Assessment of pain at least six weeks after delivery [ Time Frame: At least six weeks after delivery ] [ Designated as safety issue: No ]
pain scale assessment [ Time Frame: six weeks after birth ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Biologic Glue for First Degree Perineal Tears
Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing 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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Grade 1 Perineal Tears
  • Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
    adhesive of perineal tears
  • Procedure: 3. traditional suturing with vicryl rapid 2X0
    suturing of perineal tears grade one with vicryl rapid 2X0
  • Experimental: 1
    use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women
    Intervention: Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
  • Active Comparator: 3
    use of traditional suturing for perineal tear grade 1 in 50 women
    Intervention: Procedure: 3. traditional suturing with vicryl rapid 2X0
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
August 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00746707
feigenberg HMO-CTIL
No
Ezra Yosi, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Study Director: yosef ezra, M.D. hadassha medical organization, jerusalem israel
Hadassah Medical Organization
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP