Comparison of Absorbable Sutures in Perineal Laceration R... | NCT00223119

Studies
Comparison of Absorbable Sutures in Perineal Laceration Repair

NCT00223119

Sponsor

Medtronic - MITG

Status

Terminated

Last Update Posted

Oct 25, 2012Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Perineal Laceration Repair

Interventions

Absorbable Sutures

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study recruitment very slow.

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2012

Last Update Posted Date

Oct 25, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Absorbable Sutures	Device

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna Doran	Medtronic - MITG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
US Surgical		Norwalk	Connecticut	06856	United States