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Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure

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ClinicalTrials.gov Identifier: NCT01893463
Recruitment Status : Withdrawn
First Posted : July 9, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hemorrhage Wound Closure Bleeding Device: iTClamp50

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Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Prospective Study to Evaluate the Safety and Effectiveness of the iTClamp50 to Provide Temporary Wound Closure
Study Start Date : August 2013
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Effectiveness of the iTClamp50 to control hemorrhage [ Time Frame: Patient discharge (Varies) ]
    As measured by length of time to control bleeding and evidence of re-bleeding

  2. Number of Adverse Events [ Time Frame: Until patient discharge ]

Secondary Outcome Measures :
  1. Pain associated with application and removal of the iTClamp50 [ Time Frame: Patient discharge (varies) ]
    Pain will be observed and recorded on a scale of 1-10


Other Outcome Measures:
  1. Location of Application of the iTClamp50 [ Time Frame: Immediate ]
    Determining where the iTClamp50 was applied (scene, ambulance, emergency department).

  2. How long did it take for the iTClamp50 to be applied? [ Time Frame: immediate ]
  3. Anatomical Location of application of the iTClamp50 [ Time Frame: immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pre-hospital or emergency department patients requiring wound closure for hemorrhage control
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893463


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
Innovative Trauma Care Inc.

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Responsible Party: Innovative Trauma Care Inc.
ClinicalTrials.gov Identifier: NCT01893463     History of Changes
Other Study ID Numbers: 2013-004
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Innovative Trauma Care Inc.:
hemorrhage control
wound closure
Additional relevant MeSH terms:
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Hemorrhage
Wounds and Injuries
Pathologic Processes