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

Not Applicable

Completed

• Conditions: Needlestick Injuries; Glove Perforations
• Interventions: Device: Sharp needle; Device: Blunt needles

• Registration Number: NCT00844636
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

• Female
• Pregnant
• Undergoing a cesarean section

Exclusion Criteria

• Under age 18
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sharp Needles	Sharp needle	Sharp needles to close uterus, fascia and skin during cesarean section
Blunt Needles	Blunt needles	Assignment to blunt needles to close uterus, fascia and skin during cesarean section

Primary Outcome Measures

Name	Time	Method
Number of observed glove perforations	1 day	review post-op

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction with the needle assignment	1 day	Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States