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

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00536289
First received: September 26, 2007
Last updated: NA
Last verified: January 2006
History: No changes posted
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 and Injuries
Wounds, Stab
Wounds, Penetrating

ClinicalTrials.gov processed this record on August 28, 2014