Back to resultsDiagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries
Primary Purpose
Penetrating Injury in Upper Limb
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
exploration
Sponsored by
About this trial
This is an interventional diagnostic trial for Penetrating Injury in Upper Limb focused on measuring Clinical Examination, Accuracy, Hand, Tendon, Injury.
Eligibility Criteria
Inclusion Criteria:
Deep penetrating injury to upper limb
Exclusion Criteria:
none
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
determining damaged tissue
Arm Description
Outcomes
Primary Outcome Measures
number of determined tendon
we evalauted tendon injuries without exploration of wound
Secondary Outcome Measures
number of determined injured nerves
we evaluated the number of detemined injured nerves without exploration of wound
number of damaged arteries
we evaluated the number of detemined injured arteries without exploration of wound
Full Information
NCT ID
NCT01253863
First Posted
December 2, 2010
Last Updated
December 2, 2010
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01253863
Brief Title
Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries
Official Title
Study of Accuracy of Preoperative Examination in Penetrating Wound
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries
Detailed Description
Penetrating injuries is a common cause of severe neurovascular damage, both in adults and children.we evaluated the accuracy of the preoperative clinical examination in depicting lesions caused by penetrating wounds of hands or forearms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penetrating Injury in Upper Limb
Keywords
Clinical Examination, Accuracy, Hand, Tendon, Injury.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
determining damaged tissue
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
exploration
Intervention Description
exploration of wound for determining damaged tissue
Primary Outcome Measure Information:
Title
number of determined tendon
Description
we evalauted tendon injuries without exploration of wound
Time Frame
5 min after admission
Secondary Outcome Measure Information:
Title
number of determined injured nerves
Description
we evaluated the number of detemined injured nerves without exploration of wound
Time Frame
5 min after admision
Title
number of damaged arteries
Description
we evaluated the number of detemined injured arteries without exploration of wound
Time Frame
5 min after admission
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Deep penetrating injury to upper limb
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
(Isfahan university of medical science)
Learn more about this trial
Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries
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