Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01893463
• Other study ID #: 2013-004
• Status: Withdrawn
• Phase: N/A
• First received: June 27, 2013
• Last updated: December 18, 2013
• Start date: August 2013

Study information

• Verified date: December 2013
• Source: Innovative Trauma Care Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Wound Closure

Intervention

Device:
• iTClamp50

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Trauma Care Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Location of Application of the iTClamp50	Determining where the iTClamp50 was applied (scene, ambulance, emergency department).	Immediate	No
Other	How long did it take for the iTClamp50 to be applied?		immediate	No
Other	Anatomical Location of application of the iTClamp50		immediate	No
Primary	Effectiveness of the iTClamp50 to control hemorrhage	As measured by length of time to control bleeding and evidence of re-bleeding	Patient discharge (Varies)	No
Primary	Number of Adverse Events		Until patient discharge	Yes
Secondary	Pain associated with application and removal of the iTClamp50	Pain will be observed and recorded on a scale of 1-10	Patient discharge (varies)	No