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NCT00844636 Clinical Trial

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

Needlestick Injuries Clinical Trial

Official title:
A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00844636
Other study ID # Blunt Needles - Cesarean
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2005
Est. completion date December 2008

Study information
Verified date August 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female

- Pregnant

- Undergoing a cesarean section

Exclusion Criteria:

- Under age 18

- Non-English speaking

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sharp needle

• Blunt needles

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of observed glove perforations review post-op 1 day
Secondary Physician satisfaction with the needle assignment Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op 1 day
See also
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Completed NCT00536289 - Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth N/A
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Completed NCT02107690 - The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration N/A
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Completed NCT02107716 - Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic? N/A
Completed NCT02086292 - The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic N/A