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Comparison of Absorbable Sutures in Perineal Laceration Repair

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. Identifier: NCT00223119
Recruitment Status : Terminated (Study recruitment very slow.)
First Posted : September 22, 2005
Last Update Posted : October 25, 2012
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

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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

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00223119

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United States, Connecticut
US Surgical
Norwalk, Connecticut, United States, 06856
Sponsors and Collaborators
Medtronic - MITG
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Study Director: Donna Doran Medtronic - MITG
Layout table for additonal information Identifier: NCT00223119    
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:
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Wounds and Injuries