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

This study has been completed.

First Received on September 26, 2007. No Changes Posted

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair

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

ClinicalTrials.gov Identifier:	NCT00536289 History of Changes
Other Study ID Numbers:	MUSC HR # 10870
Study First Received:	September 26, 2007
Last Updated:	September 26, 2007
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

Additional relevant MeSH terms:

Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012