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Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier:
NCT00736580
First received: August 14, 2008
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is assessing whether there is a decrease in surgical glove punctures using blunt tipped needles compared with sharp needles for suturing during Cesarean Delivery.


Condition Intervention
Cesarean Delivery
Glove Perforation
 Other: Blunt tipped needle
Other: Sharp needles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Surgical Glove Perforation. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Direct measurement of the number of glove perforations listed by surgical case.


Secondary Outcome Measures:
  • Surgeon Satisfaction by Likert Scale. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blunt Needles
Cesarean Delivery Performed with Blunt-tipped surgical Needles
 Other: Blunt tipped needle
The Cesarean delivery is performed using blunt tipped needles.
Placebo Comparator: Sharp Needles
Cesarean delivery performed with sharp surgical needles.
 Other: Sharp needles
The cesarean is performed using standard sharp surgical suture needles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at least 18 years of age undergoing Cesarean Delivery

Exclusion Criteria:

  • Patient less than 18 years of age.
  • Patient not undergoing Cesarean Delivery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736580

Locations
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Michael L Stitely, MD West Virginia University
  More Information

No publications provided

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00736580     History of Changes
Other Study ID Numbers: H-20783
Study First Received: August 14, 2008
Results First Received: December 18, 2012
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Cesarean delivery
Surgical Needles
blunt-tip needles
surgical glove perforation

ClinicalTrials.gov processed this record on May 19, 2013