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Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries

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ClinicalTrials.gov Identifier: NCT01253863
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Penetrating Injury in Upper Limb Other: exploration Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Study of Accuracy of Preoperative Examination in Penetrating Wound
Study Start Date : August 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
determining damaged tissue Other: exploration
exploration of wound for determining damaged tissue



Primary Outcome Measures :
  1. number of determined tendon [ Time Frame: 5 min after admission ]
    we evalauted tendon injuries without exploration of wound


Secondary Outcome Measures :
  1. number of determined injured nerves [ Time Frame: 5 min after admision ]
    we evaluated the number of detemined injured nerves without exploration of wound

  2. number of damaged arteries [ Time Frame: 5 min after admission ]
    we evaluated the number of detemined injured arteries without exploration of wound



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Deep penetrating injury to upper limb

Exclusion Criteria:


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253863


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD research comittee

Additional Information:
Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01253863     History of Changes
Other Study ID Numbers: ASD-1213-7
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: August 2006

Keywords provided by Isfahan University of Medical Sciences:
Clinical Examination, Accuracy, Hand, Tendon, Injury.

Additional relevant MeSH terms:
Wounds and Injuries
Wounds, Penetrating