Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth - Tabular View

Tracking Information

First Received Date ^ICMJE

September 26, 2007

Last Updated Date

September 26, 2007

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Holes in surgeons gloves [ Time Frame: After surgical repair ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Surgeon satisfaction with the needle assignment [ Time Frame: After the surgical repair ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth

Official Title ^ICMJE

The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair

Brief Summary

The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Needlestick Injuries

Intervention ^ICMJE

Device: Blunt needle

Study Arms / Comparison Groups

Active Comparator: Sharp needles
Experimental: Blunt tipped needles

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

438

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Obstetric laceration requiring suturing

Exclusion Criteria:

< 18 years old

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00536289

Responsible Party

Study ID Numbers ^ICMJE

MUSC HR # 10870

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Scott A Sullivan, MD MSCR

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP