Back to resultsBlunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blunt needle
Sponsored by
About this trial
This is an interventional prevention trial for Needlestick Injuries focused on measuring Blunt needles, obstetric lacerations, Needlestick injuries, Needlestick injuries to physicians
Eligibility Criteria
Inclusion Criteria:
- Obstetric laceration requiring suturing
Exclusion Criteria:
- < 18 years old
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Sharp needles
Blunt tipped needles
Outcomes
Primary Outcome Measures
Holes in surgeons gloves
Secondary Outcome Measures
Surgeon satisfaction with the needle assignment
Full Information
NCT ID
NCT00536289
First Posted
September 26, 2007
Last Updated
September 26, 2007
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00536289
Brief Title
Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth
Official Title
The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needlestick Injuries
Keywords
Blunt needles, obstetric lacerations, Needlestick injuries, Needlestick injuries to physicians
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Sharp needles
Arm Title
2
Arm Type
Experimental
Arm Description
Blunt tipped needles
Intervention Type
Device
Intervention Name(s)
Blunt needle
Intervention Description
Blunt tipped suture needle
Primary Outcome Measure Information:
Title
Holes in surgeons gloves
Time Frame
After surgical repair
Secondary Outcome Measure Information:
Title
Surgeon satisfaction with the needle assignment
Time Frame
After the surgical repair
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Obstetric laceration requiring suturing
Exclusion Criteria:
< 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Sullivan, MD MSCR
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
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
Learn more about this trial
Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth
We'll reach out to this number within 24 hrs