NCT01893463

Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Innovative Trauma Care Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhage
• Wound Closure
• Bleeding

Interventions

Type	Name	Description
DEVICE	iTClamp50

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• First posted: 2013-07-09
• Last updated: 2013-12-19

Locations

1 site across 1 country: Canada