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

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ClinicalTrials.gov Identifier: NCT00844636
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : February 16, 2009
Sponsor:
Information provided by:
Medical University of South Carolina

Brief Summary:
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 or disease Intervention/treatment Phase
Glove Perforations Needlestick Injuries Device: Sharp needle Device: Blunt needles Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Study Start Date : January 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Glove perforations [ Time Frame: post-operative ]

Secondary Outcome Measures :
  1. Physician satisfaction with the needle assignment [ Time Frame: post-operative, immediate ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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): 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

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
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

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:
Wounds and Injuries
Needlestick Injuries
Wounds, Stab
Wounds, Penetrating