Comparison of Absorbable Sutures in Perineal Laceration Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-11-30

Brief Summary

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

Detailed Description

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Conditions

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Perineal Laceration Repair

Keywords

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perineal trauma perineal laceration persistent perineal pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Absorbable Sutures

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Donna Doran

Role: STUDY_DIRECTOR

Medtronic - MITG

Locations

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US Surgical

Norwalk, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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SYN03001

Identifier Type: -

Identifier Source: org_study_id