Comparison of Absorbable Sutures in Perineal Laceration Repair

This study has been terminated.
(Study recruitment very slow.)
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00223119
First received: September 13, 2005
Last updated: October 24, 2012
Last verified: October 2012

September 13, 2005
October 24, 2012
January 2004
November 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00223119 on ClinicalTrials.gov Archive Site
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Comparison of Absorbable Sutures in Perineal Laceration Repair
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The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Perineal Laceration Repair
Device: Absorbable Sutures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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November 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age
  • Able to sign informed consent
  • Vaginal laceration that requires sutures but does not involve the anal sphincter (third-degree tear) or rectal mucosa (fourth-degree tear)

Exclusion Criteria:

  • Inability to speak and understand English or Spanish
  • Previous diagnosis of vulvodynia, dyspareunia, or other chronic vulvar pain syndrome
  • Extensive perineal warts or vulvar varicosities
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223119
SYN03001
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Covidien
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Study Director: Donna Doran Covidien
Covidien
October 2012

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