Clinical trial NCT02592655: A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Vascular Injury
Keywords: tourniquet
arterial
pre-hospital
SOFTT-W
Battle Wrap
windlass
exsanguination
hemorrhage
amputation
Lead sponsor: Migura, Marcus
Sponsor class: INDIV
Collaborators: name: Mercy Health
First posted: 2015-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Upper thigh circumference greater than 61 cm or 24 inches.
2. Upper thigh circumference greater than the 50th percentile based on available anthropometric data.

Exclusion Criteria:

1. Currently taking medications for the treatment of hypertension.
2. Cardiac, renal, pulmonary, hepatic or hemologic disease or disorder.
3. 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.
4. Any coagulation disorder, prior thrombotic or embolic events such as a deep vein thrombosis.
5. Sickle cell.
6. Diabetes mellitus
7. Rheumatic arthritis or other auto immune disease.
8. Major surgery, significant traumatic injury, within 60 days trial.
9. Skin grafts on lower extremities.
10. Known or observed neurological symptoms, to include peripheral neurological symptoms or deficits.
11. Pregnant women, and women who suspect themselves to be pregnant are not eligible for this study.
12. Any known malignancy.
13. Claudication

Primary outcomes:
measure: Radiologist Limb Occlusion Assessment
timeFrame: For 1 sustained minute after application of each tourniquet intervention.
measure: Investigator Limb Occlusion Assessment
timeFrame: For 1 sustained minute after application of each tourniquet intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Vascular Medicine & Surgical Associates
state: Ohio
Study officials:
affiliation: Unafiliated
name: Marcus W Migura
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kragh JF Jr, O'Neill ML, Walters TJ, Dubick MA, Baer DG, Wade CE, Holcomb JB, Blackbourne LH. The military emergency tourniquet program's lessons learned with devices and designs. Mil Med. 2011 Oct;176(10):1144-52. doi: 10.7205/milmed-d-11-00114.
citation: Wenke JC, Walters TJ, Greydanus DJ, Pusateri AE, Convertino VA. Physiological evaluation of the U.S. Army one-handed tourniquet. Mil Med. 2005 Sep;170(9):776-81. doi: 10.7205/milmed.170.9.776.
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citation: Swan KG Jr, Wright DS, Barbagiovanni SS, Swan BC, Swan KG. Tourniquets revisited. J Trauma. 2009 Mar;66(3):672-5. doi: 10.1097/TA.0b013e3181986959.
citation: King RB, Filips D, Blitz S, Logsetty S. Evaluation of possible tourniquet systems for use in the Canadian Forces. J Trauma. 2006 May;60(5):1061-71. doi: 10.1097/01.ta.0000215429.94483.a7.
citation: Walters TJ, Mabry RL. Issues related to the use of tourniquets on the battlefield. Mil Med. 2005 Sep;170(9):770-5. doi: 10.7205/milmed.170.9.770.
citation: Walters TJ, Wenke JC, Kauvar DS, McManus JG, Holcomb JB, Baer DG. Effectiveness of self-applied tourniquets in human volunteers. Prehosp Emerg Care. 2005 Oct-Dec;9(4):416-22. doi: 10.1080/10903120500255123.
citation: Ruterbusch VL, Swiergosz MJ, Montgomery LD, Hopper KW, Gerth WA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications. Panama City, FL, US : Navy Experimental Diving Unit, November 10, 2005. NEDU Technical Report No.05-15.
citation: Hill JP, Montgomery LD, Hopper KW, Roy LA. (U) ONR/MARCORSYSCOM Evaluation of Self-Applied Tourniquets for Combat Applications, Second Phase. Panama City, FL, US : Navy Experimental Diving Unit, April 3, 2007. NEDU Technical Report No.07-07.
citation: Thomas J. Walters PhD; Joseph C. Wenke PhD; SFC Dominique; Greydanus, USA; David S. Kauvar MD, CPT, MC; David G. Baer PhD. (U) U. S. Army Institute of Surgical Research Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers, Ft. Sam Houston, TX: U. S. Army Institute of Surgical Research, September 30, 2005. USAISR Technical Report No.2005-05