Comparison of Absorbable Sutures in Perineal Laceration Repair

Medtronic

Status and phase: Terminated; Phase 4

Conditions: Perineal Laceration Repair

Treatments: Device: Absorbable Sutures

Study type: Interventional

Funder types: Industry

Identifiers

NCT00223119

SYN03001

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind