Back to resultsA Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Primary Purpose
Glove Perforations, Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sharp needle
Blunt needles
Sponsored by
About this trial
This is an interventional prevention trial for Glove Perforations focused on measuring Needlestick injuries, Glove perforations, Blunt Needles, Glove perforations of surgeons, assistants, Needlestick injuries of same
Eligibility Criteria
Inclusion Criteria:
- Female
- Pregnant
- Undergoing a cesarean section
Exclusion Criteria:
- Under age 18
- Non-English speaking
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sharp Needles
Blunt Needles
Arm Description
Sharp needles to close uterus, fascia and skin during cesarean section
Assignment to blunt needles to close uterus, fascia and skin during cesarean section
Outcomes
Primary Outcome Measures
Number of observed glove perforations
review post-op
Secondary Outcome Measures
Physician satisfaction with the needle assignment
Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op
Full Information
NCT ID
NCT00844636
First Posted
February 12, 2009
Last Updated
August 9, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00844636
Brief Title
A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Official Title
A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glove Perforations, Needlestick Injuries
Keywords
Needlestick injuries, Glove perforations, Blunt Needles, Glove perforations of surgeons, assistants, Needlestick injuries of same
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sharp Needles
Arm Type
Active Comparator
Arm Description
Sharp needles to close uterus, fascia and skin during cesarean section
Arm Title
Blunt Needles
Arm Type
Active Comparator
Arm Description
Assignment to blunt needles to close uterus, fascia and skin during cesarean section
Intervention Type
Device
Intervention Name(s)
Sharp needle
Intervention Type
Device
Intervention Name(s)
Blunt needles
Primary Outcome Measure Information:
Title
Number of observed glove perforations
Description
review post-op
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Physician satisfaction with the needle assignment
Description
Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Pregnant
Undergoing a cesarean section
Exclusion Criteria:
Under age 18
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Sullivan, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29466
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19622979
Citation
Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2009 Aug;114(2 Pt 1):211-216. doi: 10.1097/AOG.0b013e3181ae9b4a.
Results Reference
derived
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A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
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