A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
Condition: Hemorrhage; Vascular Injury
MeSH terms: Vascular System Injuries; Hemorrhage
Study type: Interventional

Summary: 
      This cross-over study of twenty five (anticipated) 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 description: 
      This is a small study of 19 participants conducted over only two days. All data for this
      study is collected by the study.

      Tourniquet application:

      All tourniquet applications conducted with the participant seated on the edge of an exam
      table with one leg hanging off the side, and the leg for tourniquet application extended
      outward, with the mid calf resting on a support. This position permits access to the
      popliteal artery for ultrasonography while the investigator has access to apply the
      tourniquet. The lower edge of each tourniquet is aligned just above the middle of the thigh.
      All tourniquets are applied over the pressure mapping sensor. The sensor is slightly thicker
      than denim jeans. Extra care must be taken to ensure that the material of the sensor does not
      interfere with removing the slack from the windlass tourniquets before turning the windlass
      to apply final pressure.

      When a second windlass tourniquet is to be applied it is applied just above or proximal to
      the first windlass tourniquet. The windlass of each tourniquet are located as far from each
      other as possible. Meaning that if the windlass of the first tourniquet is the twelve o'clock
      position then the windlass of the second tourniquet is positioned at the six o'clock
      position. The strap of each tourniquet cannot slip over the windlass of the other. This 6 and
      12 positioning prevents the strap of the second windlass tourniquet from slipping over the
      first as it is tightened.

      When the tape tourniquet is applied, it is elongated, stretched as it is layered over the
      preceding layer with at least one half over lap. The tape tourniquet used in this study is
      similar to, but not the same as the product called manufactured by Entrotech, called "Battle
      Wrap." Results similar to this study should not be expected with the "Battle Wrap" product.
    

Intervention name(s): Pneumatic Tourniquet; One Windlass Tourniquet; Two Windlass Tourniquets; Tourniquet Tape 5 cm; Tourniquet Tape 10 cm
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Automated pneumatic tourniquet, applied to middle upper thigh.; One Windlass Tourniquet 3.8 cm (1.5 inch) wide. A Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) will be used for the windlass tourniquet. One windlass tourniquet will be applied to the middle upper thigh.; Two Windlass Tourniquets will be applied by applying a second 3.8 cm (1.5 inch) wide windlass tourniquet immediately proximal to the first windlass tourniquet.; Tourniquet Tape is 5 cm (2 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.; Tourniquet Tape is 10 cm (4 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.
Other intervention name(s): Zimmer Automatic Tourniquet System (ATS) 1500; Special Operations Forces Tactical Tourniquet Wide (SOFTT-W)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tourniquet; arterial; pre-hospital; SOFTT-W; Battle Wrap; windlass; exsanguination; hemorrhage; amputation