Clinical Trial: A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Sequence, Assessor-Blind, Cross-Over Study of a Windlass Tourniquet, a Pneumatic Tourniquet and an Elastic Adhesive Bandage for Use as a Tourniquet

Brief Summary: This cross-over study of twenty five healthy human subjects will utilize two active control devices, and two different widths of the investigational device. One active control is representative of the usual care tourniquet applied in hospital settings. The second active control is a windlass tourniquet representative of the pre-hospital and military usual care tourniquet device. Two inch and four inch widths of the investigational device will be evaluated. The purpose of this study is to characterize and compare investigational and control tourniquet safety and efficacy. All tourniquets will be applied to the upper thigh. Efficacy data is provided by the presence or absence of popliteal flow when assessed with ultrasound. Mapping of interface pressures between the skin and the tourniquet will provide safety data. A minimum washout of five minutes will be allowed between tourniquet applications. All interventions will be applied in one visit. No follow up visit is anticipated.

Detailed Summary:
Sponsor: Marcus Migura

Current Primary Outcome:

  • Flow Assessment Automatic Tourniquet System (ATS) [ Time Frame: After application of Automatic Tourniquet System (ATS) on visit day 1 ]
    Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
  • Flow Assessment Windlass Single Tourniquet SOFTT-W [ Time Frame: After application of a Single Windlass Tourniquet SOFTT-W on visit day 1 ]
    Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
  • Flow Assessment Double Windlass Tourniquet SOFTT-W [ Time Frame: After application of a Second Tourniquet SOFTT-W on visit day 1 ]

    A second windlass tourniquet will be applied only if a single windlass tourniquet appears to be ineffective.

    Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow&quo

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Tourniquet Interface Pressure Automatic Tourniquet System (ATS) [ Time Frame: After the application of Automatic Tourniquet System (ATS) on visit day 1 ]
      The "Tactilus" pressure mapping system will be used to continuously monitor the tourniquet interface pressure. The mean pressure measured during flow assessment will be recorded. This device is reported to have a ten percent error.
    • Tourniquet Interface Pressure Single Windlass Tourniquet SOFTT-W [ Time Frame: After application of a Single Windlass Tourniquet SOFTT-W on visit day 1 ]
      The "Tactilus" pressure mapping system will be used to continuously monitor the tourniquet interface pressure. The mean pressure measured during flow assessment will be recorded. This device is reported to have a ten percent error.
    • Tourniquet Interface Pressure Double Windlass Tourniquet SOFTT-W [ Time Frame: After application of a Second Windlass Tourniquet SOFTT-W on visit day 1 ]
      The "Tactilus" pressure mapping system will be used to continuously monitor the tourniquet interface pressure. The mean pressure measured during flow assessment will be recorded. This device is reported to have a ten percent error.
    • Tourniquet Interface Pressure Battle Wrap TQ Tape 5 cm [ Time Frame: After application of Battle Wrap TQ Tape 5 cm on visit day 1 ]
      The "Tactilus" pressure mapping system will be used to continuously monitor the tourniquet interface pressure. The mean pressure measured during flow assessment will be recorded. This device is reported to have a ten percent error.
    • Tourniquet Interface Pressure Battle Wrap TQ Tape 10 cm [ Time Frame: After application of Battle Wrap TQ Tape 10 cm on visit day 1 ]
      The "Tactilus" pressure mapping system will be used to continuously monitor the tourniquet interface pressure. The mean pressure measured during flow assessment will be recorded. This device is reported to have a ten percent error.


    Information By: Migura, Marcus

    Dates:
    Date Received: October 27, 2015
    Date Started: December 2015
    Date Completion:
    Last Updated: January 13, 2016
    Last Verified: January 2016