NCT00844636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

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
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

February 12, 2009

Last Update Submit

August 9, 2018

Conditions

Glove PerforationsNeedlestick Injuries

Keywords

Needlestick injuriesGlove perforationsBlunt NeedlesGlove perforations of surgeons, assistantsNeedlestick injuries of same

Outcome Measures

Primary Outcomes (1)

  • Number of observed glove perforations

    review post-op

    1 day

Secondary Outcomes (1)

  • Physician satisfaction with the needle assignment

    1 day

Study Arms (2)

Sharp Needles

ACTIVE COMPARATOR

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

Device: Sharp needle

Blunt Needles

ACTIVE COMPARATOR

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

Device: Blunt needles

Interventions

Sharp needleDEVICE
Sharp Needles
Blunt needlesDEVICE
Blunt Needles

Eligibility Criteria

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

You may qualify if:

  • Female
  • Pregnant
  • Undergoing a cesarean section

You may not qualify if:

  • Under age 18
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29466, United States

Location

Related Publications (1)

  • 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.

    PMID: 19622979DERIVED

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Study Officials

  • Scott A Sullivan, MD

    Medical University of South Carolina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 16, 2009

Study Start

January 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(1)