Comparison of Absorbable Sutures in Perineal Laceration Repair

Perineal Laceration Repair Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00223119
• Other study ID #: SYN03001
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 24, 2012
• Start date: January 2004
• Est. completion date: November 2005

Study information

• Verified date: October 2012
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations
• Perineal Laceration Repair

Intervention

Device:
• Absorbable Sutures

Locations

Country	Name	City	State
United States	US Surgical	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States,