Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

Withdrawn

• Conditions: Hemorrhage; Wound Closure; Bleeding
• Interventions: Device: iTClamp50

• Registration Number: NCT01893463
• Lead Sponsor: Innovative Trauma Care Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Study Start: 2013-08
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients which received the iTClamp as treatment	iTClamp50	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.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Until patient discharge
Effectiveness of the iTClamp50 to control hemorrhage	Patient discharge (Varies)	As measured by length of time to control bleeding and evidence of re-bleeding

Secondary Outcome Measures

Name	Time	Method
Pain associated with application and removal of the iTClamp50	Patient discharge (varies)	Pain will be observed and recorded on a scale of 1-10

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada