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TerminatedNCT00223119Updated Oct 25, 2012

Comparison of Absorbable Sutures in Perineal Laceration Repair

A Phase 4 interventional study of Absorbable Sutures in Perineal Laceration Repair, sponsored by Medtronic - MITG. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-25.

Sponsored by Medtronic - MITG · Phase 4, Interventional, and Treatment

Why this study was terminated
Study recruitment very slow.
Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Perineal Laceration Repair

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Keywords

  • perineal trauma
  • perineal laceration
  • persistent perineal pain
03

In context

Lacerations

133 studies on the registry are indexed under Lacerations; 29 are open to participants now.

Browse Lacerations studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double

Interventions

  • DeviceAbsorbable Sutures
06

Study locations

1 site
  • US Surgical
    Norwalk, Connecticut 06856, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00223119
Lead sponsor
Medtronic - MITG
First posted
Sep 22, 2005
Start date
Jan 2004
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Oct 25, 2012

Study contacts

Donna Doran
study director · Medtronic - MITG
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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