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Early and effective control of severe bleeding is critical to survival of trauma patients. The iTClampâ„¢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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTClamp50 | Device |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Location of Application of the iTClamp50 | Determining where the iTClamp50 was applied (scene, ambulance, emergency department). | Immediate |
| How long did it take for the iTClamp50 to be applied? | immediate |
Inclusion Criteria:
Exclusion Criteria:
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Pre-hospital or emergency department patients requiring wound closure for hemorrhage control
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Anatomical Location of application of the iTClamp50 | immediate |