An observational study in Hemorrhage, Wound Closure and Bleeding, sponsored by Innovative Trauma Care Inc.. Withdrawn at 1 site in Canada. Per ClinicalTrials.gov, last updated 2013-12-19.
Sponsored by Innovative Trauma Care Inc. · Observational
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
Browse Hemorrhage studies →This is the only study on the registry with Innovative Trauma Care Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Pre-hospital or emergency department patients requiring wound closure for hemorrhage control
Exclusion Criteria:
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
Effectiveness of the iTClamp50 to control hemorrhage
As measured by length of time to control bleeding and evidence of re-bleeding
Time frame: Patient discharge (Varies)
Number of Adverse Events
Time frame: Until patient discharge
Pain associated with application and removal of the iTClamp50
Pain will be observed and recorded on a scale of 1-10
Time frame: Patient discharge (varies)
Location of Application of the iTClamp50
Determining where the iTClamp50 was applied (scene, ambulance, emergency department).
Time frame: Immediate
How long did it take for the iTClamp50 to be applied?
Time frame: immediate
Anatomical Location of application of the iTClamp50
Time frame: immediate
This study is withdrawn, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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