Bleeding, Hemorrhage, Wound Closure
Conditions
Keywords
hemorrhage control, wound closure
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 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.
Interventions
DEVICEiTClamp50
Sponsors
Innovative Trauma Care Inc.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the iTClamp50 to control hemorrhage | Patient discharge (Varies) | As measured by length of time to control bleeding and evidence of re-bleeding |
| Number of Adverse Events | Until patient discharge | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with application and removal of the iTClamp50 | Patient discharge (varies) | Pain will be observed and recorded on a scale of 1-10 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Location of Application of the iTClamp50 | Immediate | Determining where the iTClamp50 was applied (scene, ambulance, emergency department). |
| How long did it take for the iTClamp50 to be applied? | immediate | — |
| Anatomical Location of application of the iTClamp50 | immediate | — |
Countries
Canada
Outcome results
None listed