Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

Study Overview
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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.

Official Title
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Prospective Study to Evaluate the Safety and Effectiveness of the iTClamp50 to Provide Temporary Wound Closure

Conditions
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Hemorrhage, Wound Closure, Bleeding

Intervention / Treatment
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* Device: iTClamp50


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients which received the iTClamp as treatment<br>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. | Device: iTClamp50<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the iTClamp50 to control hemorrhage | As measured by length of time to control bleeding and evidence of re-bleeding | Patient discharge (Varies) | 
| Number of Adverse Events |  | Until patient discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with application and removal of the iTClamp50 | Pain will be observed and recorded on a scale of 1-10 | Patient discharge (varies) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhage control, wound closure