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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536289
First Posted: September 27, 2007
Last Update Posted: September 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of South Carolina
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obstetric laceration requiring suturing

Exclusion Criteria:

  • < 18 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00536289     History of Changes
Other Study ID Numbers: MUSC HR # 10870
First Submitted: September 26, 2007
First Posted: September 27, 2007
Last Update Posted: September 27, 2007
Last Verified: January 2006

Keywords provided by Medical University of South Carolina:
Blunt needles
obstetric lacerations
Needlestick injuries
Needlestick injuries to physicians

Additional relevant MeSH terms:
Wounds and Injuries
Needlestick Injuries
Wounds, Stab
Wounds, Penetrating