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A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00844636
First received: February 12, 2009
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.


Condition Intervention
Glove Perforations
Needlestick Injuries
 Device: Sharp needle
Device: Blunt needles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

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

Primary Outcome Measures:
  • Glove perforations [ Time Frame: post-operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physician satisfaction with the needle assignment [ Time Frame: post-operative, immediate ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sharp Needles
Sharp needles to close uterus, fascia and skin during cesarean section
 Device: Sharp needle
Active Comparator: Blunt Needles
Assignment to blunt needles to close uterus, fascia and skin during cesarean section
 Device: Blunt needles

  Eligibility

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

Inclusion Criteria:

  • Female
  • Pregnant
  • Undergoing a cesarean section

Exclusion Criteria:

  • Under age 18
  • Non-English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844636

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
Study Director: Scott A Sullivan, MD Medical University of South Carolina
  More Information

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bridget Williamson MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00844636     History of Changes
Other Study ID Numbers: Blunt Needles - Cesarean
Study First Received: February 12, 2009
Last Updated: February 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Needlestick injuries
Glove perforations
Blunt Needles
Glove perforations of surgeons, assistants
Needlestick injuries of same

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

ClinicalTrials.gov processed this record on June 17, 2013