NCT00223119

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

October 24, 2012

Conditions

Perineal Laceration Repair

Keywords

perineal traumaperineal lacerationpersistent perineal pain

Interventions

Absorbable SuturesDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Surgical

Norwalk, Connecticut, 06856, United States

Location

Study Officials

  • Donna Doran

    Medtronic - MITG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

US(1)