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

NCT ID: NCT00844636

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Glove Perforations Needlestick Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sharp Needles

Sharp needles to close uterus, fascia and skin during cesarean section

Group Type ACTIVE_COMPARATOR

Sharp needle

Intervention Type DEVICE

Blunt Needles

Assignment to blunt needles to close uterus, fascia and skin during cesarean section

Group Type ACTIVE_COMPARATOR

Blunt needles

Intervention Type DEVICE

Interventions

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Sharp needle

Intervention Type DEVICE

Blunt needles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female
* Pregnant
* Undergoing a cesarean section

Exclusion Criteria

* Under age 18
* Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Medical University of South Carolina

Principal Investigators

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Scott A Sullivan, MD

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2009 Aug;114(2 Pt 1):211-216. doi: 10.1097/AOG.0b013e3181ae9b4a.

Reference Type DERIVED
PMID: 19622979 (View on PubMed)

Other Identifiers

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Blunt Needles - Cesarean

Identifier Type: -

Identifier Source: org_study_id

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