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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014