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Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

NCT ID: NCT01893463

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Brief Summary

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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 controls bleeding by sealing the skin. Similar to a clip, the device seals the skin edges within a pressure bar, enabling the creation of a hematoma where blood collects under pressure to form a stable clot until definitive repair. The iTClamp50 is indicated for use as a skin closure device for short-term soft tissue approximation, including use in trauma wounds, lacerations, junctional bleeds or surgical incisions. The purpose of this prospective clinical study is to evaluate the effectiveness and safety of the iTClamp50 in the ambulance (pre-hospital) and emergency department setting. This will be accomplished by observing patients with the device applied from the pre-hospital through to patient discharge. The hypothesis is that the iTClamp50 will be safe and effective at providing temporary wound closure to control hemorrhage in the pre-hospital and emergency department setting.

Detailed Description

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Conditions

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Hemorrhage Wound Closure Bleeding

Keywords

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hemorrhage control wound closure

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients which received the iTClamp as treatment

Use of the iTClamp50 will be determined by the EMS and ER physicians. Patients who have received treatment will be tracked from pre-hospital to patient discharge (chart review). EMS care providers and physicians will answer a survey about their experience with the iTClamp50.

iTClamp50

Intervention Type DEVICE

Interventions

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iTClamp50

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Trauma Care Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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2013-004

Identifier Type: -

Identifier Source: org_study_id