Diagnostic Accuracy of the Preoperative Clinical Examinat... | NCT01253863

Studies
Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries

NCT01253863

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

250Actual

Phase

Phase 2

Conditions

Penetrating Injury in Upper Limb

Interventions

exploration

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

May 2008Actual

Completion Date

Sep 2009Actual

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
determining damaged tissue	Other		Other: exploration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exploration	Other	exploration of wound for determining damaged tissue	determining damaged tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of determined tendon	we evalauted tendon injuries without exploration of wound	5 min after admission

Secondary Outcomes

Measure	Description	Time Frame
number of determined injured nerves	we evaluated the number of detemined injured nerves without exploration of wound	5 min after admision
number of damaged arteries	we evaluated the number of detemined injured arteries without exploration of wound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Deep penetrating injury to upper limb

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hamidreza shemshaki, MD	research comittee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-zahra university hospital		Isfahan	Isfahan		Iran

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013026	Space Flight

Ancestor Terms

ID	Term
D001359	Aviation
D014186	Transportation
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided