Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

NCT01893463 | Withdrawn

• 1 other identifier: 2013-004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Wound Closure; Bleeding

Keywords

hemorrhage control; wound closure

Outcome Measures

Primary Outcomes (2)

• Effectiveness of the iTClamp50 to control hemorrhage

  As measured by length of time to control bleeding and evidence of re-bleeding

  Patient discharge (Varies)

• Number of Adverse Events

  Until patient discharge

Secondary Outcomes (1)

• Pain associated with application and removal of the iTClamp50

  Patient discharge (varies)

Other Outcomes (3)

• Location of Application of the iTClamp50

  Immediate

• How long did it take for the iTClamp50 to be applied?

  immediate

• Anatomical Location of application of the iTClamp50

  immediate

Study Arms (1)

Patients which received the iTClamp as treatment

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

Interventions

iTClamp50 DEVICE

Patients which received the iTClamp as treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre-hospital or emergency department patients requiring wound closure for hemorrhage control

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovative Trauma Care Inc.: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 9, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

CA (1)