Back to resultsComparison of Absorbable Sutures in Perineal Laceration Repair
Primary Purpose
Perineal Laceration Repair
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Absorbable Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Perineal Laceration Repair focused on measuring perineal trauma, perineal laceration, persistent perineal pain
Eligibility 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
Sites / Locations
- US Surgical
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00223119
Brief Title
Comparison of Absorbable Sutures in Perineal Laceration Repair
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Study recruitment very slow.
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic - MITG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Laceration Repair
Keywords
perineal trauma, perineal laceration, persistent perineal pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Absorbable Sutures
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Doran
Organizational Affiliation
Medtronic - MITG
Official's Role
Study Director
Facility Information:
Facility Name
US Surgical
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Absorbable Sutures in Perineal Laceration Repair
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