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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00536289
Other study ID # MUSC HR # 10870
Secondary ID
Status Completed
Phase N/A
First received September 26, 2007
Last updated September 26, 2007
Start date January 2005
Est. completion date September 2006

Study information

Verified date January 2006
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 438
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Obstetric laceration requiring suturing

Exclusion Criteria:

- < 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Blunt needle
Blunt tipped suture needle

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 Holes in surgeons gloves After surgical repair
Secondary Surgeon satisfaction with the needle assignment After the surgical repair
See also
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Active, not recruiting NCT06199765 - Risk Perception of Needlestick Injury N/A
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Completed NCT02107729 - The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic N/A
Completed NCT02086292 - The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic N/A
Completed NCT02107742 - The Influence of Injection Speed on Pain During Administration of Local Anaesthetic. N/A
Completed NCT02107716 - Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic? N/A