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

This study has been completed.

First Received: September 26, 2007 No Changes Posted

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00536289

Purpose

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.

Condition	Intervention
Needlestick Injuries	Device: Blunt needle

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	438
Study Start Date:	January 2005
Study Completion Date:	September 2006

Arms	Assigned Interventions
1: Active Comparator Sharp needles	Device: Blunt needle Blunt tipped suture needle
2: Experimental Blunt tipped needles	Device: Blunt needle Blunt tipped suture needle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Obstetric laceration requiring suturing

Exclusion Criteria:

< 18 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536289

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29466

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Scott A Sullivan, MD MSCR

Medical University of South Carolina

More Information

No publications provided

Study ID Numbers:	MUSC HR # 10870
Study First Received:	September 26, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00536289 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Blunt needles
obstetric lacerations
Needlestick injuries
Needlestick injuries to physicians

Study placed in the following topic categories:

Lacerations
Wounds, Penetrating
Wounds and Injuries
Needlestick Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Wounds, Penetrating
Wounds, Stab
Wounds and Injuries
Needlestick Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 11, 2009