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

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ClinicalTrials.gov Identifier: NCT00536289
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Needlestick Injuries Device: Blunt needle

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
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
Study Start Date : January 2005
Study Completion Date : September 2006
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Sharp needles
Device: Blunt needle
Blunt tipped suture needle
Experimental: 2
Blunt tipped needles
Device: Blunt needle
Blunt tipped suture needle

Outcome Measures

Primary Outcome Measures :
  1. Holes in surgeons gloves [ Time Frame: After surgical repair ]

Secondary Outcome Measures :
  1. Surgeon satisfaction with the needle assignment [ Time Frame: After the surgical repair ]

Eligibility Criteria

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

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

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29466
Sponsors and Collaborators
Medical University of South Carolina
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 Posted: September 27, 2007    Key Record Dates
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