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
  Purpose

The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.


Condition Intervention Phase
Perineal Laceration Repair
Device: Absorbable Sutures
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by Covidien:

Study Start Date: January 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223119

Locations
United States, Connecticut
US Surgical
Norwalk, Connecticut, United States, 06856
Sponsors and Collaborators
Covidien
Investigators
Study Director: Donna Doran Covidien
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223119     History of Changes
Other Study ID Numbers: SYN03001
Study First Received: September 13, 2005
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
perineal trauma
perineal laceration
persistent perineal pain

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014