NCT01253863

Brief Summary

The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

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

August 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
Last Updated

December 3, 2010

Status Verified

August 1, 2006

Enrollment Period

1.8 years

First QC Date

December 2, 2010

Last Update Submit

December 2, 2010

Conditions

Penetrating Injury in Upper Limb

Keywords

Clinical Examination, Accuracy, Hand, Tendon, Injury.

Outcome Measures

Primary Outcomes (1)

  • number of determined tendon

    we evalauted tendon injuries without exploration of wound

    5 min after admission

Secondary Outcomes (2)

  • number of determined injured nerves

    5 min after admision

  • number of damaged arteries

    5 min after admission

Study Arms (1)

determining damaged tissue

OTHER
Other: exploration

Interventions

explorationOTHER

exploration of wound for determining damaged tissue

determining damaged tissue

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Deep penetrating injury to upper limb

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Space Flight

Intervention Hierarchy (Ancestors)

AviationTransportationTechnology, Industry, and Agriculture

Study Officials

  • hamidreza shemshaki, MD

    research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Study Completion

September 1, 2009

Last Updated

December 3, 2010

Record last verified: 2006-08

Locations

IR(1)