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Comparison of Absorbable Sutures in Perineal Laceration Repair

This study has been terminated.
(Study recruitment very slow.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223119
First Posted: September 22, 2005
Last Update Posted: October 25, 2012
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.
Information provided by:
Medtronic - MITG
  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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223119


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

ClinicalTrials.gov Identifier: NCT00223119     History of Changes
Other Study ID Numbers: SYN03001
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by Medtronic - MITG:
perineal trauma
perineal laceration
persistent perineal pain

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries