NCT00536289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

September 27, 2007

Status Verified

January 1, 2006

First QC Date

September 26, 2007

Last Update Submit

September 26, 2007

Conditions

Needlestick Injuries

Keywords

Blunt needlesobstetric lacerationsNeedlestick injuriesNeedlestick injuries to physicians

Outcome Measures

Primary Outcomes (1)

  • Holes in surgeons gloves

    After surgical repair

Secondary Outcomes (1)

  • Surgeon satisfaction with the needle assignment

    After the surgical repair

Study Arms (2)

1

ACTIVE COMPARATOR

Sharp needles

Device: Blunt needle

2

EXPERIMENTAL

Blunt tipped needles

Device: Blunt needle

Interventions

Blunt needleDEVICE

Blunt tipped suture needle

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstetric laceration requiring suturing

You may not qualify if:

  • \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29466, United States

Location

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Study Officials

  • Scott A Sullivan, MD MSCR

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

January 1, 2005

Study Completion

September 1, 2006

Last Updated

September 27, 2007

Record last verified: 2006-01

Locations

US(1)