Hemorrhage Clinical Trial
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
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.
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.
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