Status:

WITHDRAWN

Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

Lead Sponsor:

Innovative Trauma Care Inc.

Conditions:

Hemorrhage

Wound Closure

Eligibility:

All Genders

Brief Summary

Early and effective control of severe bleeding is critical to survival of trauma patients. The iTClamp™50 is a Health Canada approved medical device for temporary wound/skin closure that quickly contr...

Eligibility Criteria

Inclusion

  • The device is indicated for use to control external hemorrhage from all compressible areas and to close wounds on the torso (chest and abdomen). The final decision to apply the device will be left with the care provider; however, their rationale will be reviewed in the post-use questionnaire.

Exclusion

  • The device is contraindicated for application to specific regions (e.g., eyes and genitals), application on patients less than the size of maturity, and wounds in which the skin edges cannot be approximated.

Key Trial Info

Start Date :

August 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01893463

Start Date

August 1 2013

Last Update

December 19 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Alberta

Edmonton, Alberta, Canada