Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth

September 26, 2007 updated by: Medical University of South Carolina

The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29466
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obstetric laceration requiring suturing

Exclusion Criteria:

  • < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Sharp needles
Device: Blunt needle
Blunt tipped suture needle
Experimental: 2
Blunt tipped needles
Device: Blunt needle
Blunt tipped suture needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Holes in surgeons gloves
Time Frame: After surgical repair
After surgical repair

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgeon satisfaction with the needle assignment
Time Frame: After the surgical repair
After the surgical repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Scott A Sullivan, MD MSCR, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Estimate)

September 27, 2007

Last Update Submitted That Met QC Criteria

September 26, 2007

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSC HR # 10870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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