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Comparison of Absorbable Sutures in Perineal Laceration Repair

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ClinicalTrials.gov Identifier: NCT00223119
Recruitment Status : Terminated (Study recruitment very slow.)
First Posted : September 22, 2005
Last Update Posted : October 25, 2012
Sponsor:
Information provided by:
Medtronic - MITG

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

Condition or disease Intervention/treatment Phase
Perineal Laceration Repair Device: Absorbable Sutures Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources





Information from the National Library of Medicine

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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

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

ClinicalTrials.gov Identifier: NCT00223119     History of Changes
Other Study ID Numbers: SYN03001
First Posted: September 22, 2005    Key Record Dates
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