At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Sequence, Assessor-Blind, Cross-Over Study of a Windlass Tourniquet, a Pneumatic Tourniquet and an Elastic Adhesive Bandage for Use as a Tourniquet
In Brief
A clinical study evaluating Pneumatic Tourniquet, One Windlass Tourniquet, and 3 other interventions for Hemorrhage and Vascular Injury. Completed, enrolled 19 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.