N/A
N=19
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
Hemorrhage · Vascular Injury
Bottom Line
View on ClinicalTrials.gov: NCT02592655 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Radiologist Limb Occlusion Assessment — 19; 18; 8; 8 Participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pneumatic Tourniquet (Device); One Windlass Tourniquet (Device); Two Windlass Tourniquets (Device); Tourniquet Tape 5 cm (Device); Tourniquet Tape 10 cm (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marcus Migura
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiologist Limb Occlusion Assessment |
19; 18; 8; 8; 0; 0 | 0.002 sig |
| PRIMARY Investigator Limb Occlusion Assessment |
19; 19; 8; 9; 3; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Upper thigh circumference greater than 61 cm or 24 inches.
- Upper thigh circumference greater than the 50th percentile based on available anthropometric data.
Exclusion Criteria
- Currently taking medications for the treatment of hypertension.
- Cardiac, renal, pulmonary, hepatic or hemologic disease or disorder.
- Patients with signs or symptoms of vascular insufficiency. Specifically, patients with any history of non-healing wound, ulcer, blood clots or peripheral vascular disease will be excluded.
- Any coagulation disorder, prior thrombotic or embolic events such as a deep vein thrombosis.
- Sickle cell.
- Diabetes mellitus
- Rheumatic arthritis or other auto immune disease.
- Major surgery, significant traumatic injury, within 60 days trial.
- Skin grafts on lower extremities.
- Known or observed neurological symptoms, to include peripheral neurological symptoms or deficits.
- Pregnant women, and women who suspect themselves to be pregnant are not eligible for this study.
- Any known malignancy.
- Claudication
Data sourced from ClinicalTrials.gov (NCT02592655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.