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Biologic Glue for First Degree Perineal Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00746707
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):
Ezra Yosi, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date December 20, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2011)
Functional and cosmetic evaluation of perineal tear area. [ Time Frame: At least six weeks after birth ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Functional and cosmetic evaluation of perineal tear area. [ Time Frame: six weeks after birth ]
Change History Complete list of historical versions of study NCT00746707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2011)
Assessment of pain at least six weeks after delivery [ Time Frame: At least six weeks after delivery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
pain scale assessment [ Time Frame: six weeks after birth ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biologic Glue for First Degree Perineal Tears
Official Title  ICMJE Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears
Brief Summary The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Grade 1 Perineal Tears
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2011)
102
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2008)
150
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746707
Other Study ID Numbers  ICMJE feigenberg HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ezra Yosi, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: yosef ezra, M.D. hadassha medical organization, jerusalem israel
PRS Account Hadassah Medical Organization
Verification Date December 2011

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