IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 7 of 7 for:
"Exsanguination"
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
This study has been completed.
Sponsor:
Marcus Migura
Collaborator:
Mercy Health
Information provided by (Responsible Party):
Marcus Migura, Migura, Marcus
ClinicalTrials.gov Identifier:
NCT02592655
First received: October 27, 2015
Last updated: January 13, 2016
Last verified: January 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This cross-over study of twenty five 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.
| Condition | Intervention |
|---|---|
| Hemorrhage Vascular Injury | Device: Automatic Tourniquet System (ATS) Device: Single Windlass Tourniquet SOFTT-W Device: Double Windlass Tourniquet SOFTT-W Device: Battle Wrap TQ Tape 5 cm Device: Battle Wrap TQ Tape 10 cm |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Further study details as provided by Marcus Migura, Migura, Marcus:
Primary Outcome Measures:
- Flow Assessment Automatic Tourniquet System (ATS) [ Time Frame: After application of Automatic Tourniquet System (ATS) on visit day 1 ]Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
- Flow Assessment Windlass Single Tourniquet SOFTT-W [ Time Frame: After application of a Single Windlass Tourniquet SOFTT-W on visit day 1 ]Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
- Flow Assessment Double Windlass Tourniquet SOFTT-W [ Time Frame: After application of a Second Tourniquet SOFTT-W on visit day 1 ]
A second windlass tourniquet will be applied only if a single windlass tourniquet appears to be ineffective.
Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
- Flow Assessment Battle Wrap TQ Tape 5 cm [ Time Frame: After the application of Battle Wrap TQ Tape 5 cm on visit day 1 ]Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
- Flow Assessment Battle Wrap TQ Tape 10 cm [ Time Frame: After the application of Battle Wrap TQ Tape 10 cm on visit day 1 ]Perfusion as measured by Doppler color flow ultrasound at the popliteal artery. "Flow" or "NO Flow" judgments will be made by the investigators and separately by the outcome assessor. The outcome assessor will be limited to "flow" or "No Flow" responses, while the investigators will have additional options which are included for explanatory purposes. Final assessment of flow will be made after one minute of occlusion is observed.
| Enrollment: | 19 |
| Study Start Date: | December 2015 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Automatic Tourniquet System (ATS)
Each subject has been randomly allocated to 1 of the 24 possible sequences of the 4 interventions to be applied over the 4 periods (6, 4x4 Latin squares). The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) is a pneumatic tourniquet that is typically used in surgical settings, and is representative of best outcome under the ideal circumstances of a controlled environment.
|
Device: Automatic Tourniquet System (ATS)
Automated pneumatic tourniquet.
Other Name: Zimmer ATS 1500
|
|
Active Comparator: Single SOFTT-W, Double SOFTT-W
Each subject has been randomly allocated to 1 of the 24 possible sequences of the 4 interventions to be applied over the 4 periods (6, 4x4 Latin squares). The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.81 cm (1.5 inch) in width. The SOFTT-W is representative of the typical use device in civilian prehospital and military combat environments. Single Windlass Tourniquet SOFTT-W If the interface pressure of the Single SOFTT-W is above 350 mmHg without achieving occlusion then a second SOFTT-W will be applied immediately proximal to the first. This is what is referred to as a Double Windlass Tourniquet SOFTT-W configuration. |
Device: Single Windlass Tourniquet SOFTT-W
The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is a 3.81 cm (1.5 inch) wide windlass tourniquet.
Other Name: Single SOFTT-W
Device: Double Windlass Tourniquet SOFTT-W
The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is a 3.81 cm (1.5 inch) wide windlass tourniquet.
Other Name: Double SOFTT-W
|
|
Experimental: Battle Wrap TQ Tape 5 cm
Each subject has been randomly allocated to 1 of the 24 possible sequences of the 4 interventions to be applied over the 4 periods (6, 4x4 Latin squares). Battle Wrap Tourniquet Tape, 5.08 cm (2 inch) width 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.
|
Device: Battle Wrap TQ Tape 5 cm
Battle Wrap Tourniquet Tape is 5.08 cm (2 inch) in width. BW TQ 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 Name: BW5 TQ Tape
|
|
Experimental: Battle Wrap TQ Tape 10 cm
Each subject has been randomly allocated to 1 of the 24 possible sequences of the 4 interventions to be applied over the 4 periods (6, 4x4 Latin squares). Battle Wrap Tourniquet Tape, 10.16 cm (4 inch) width 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.
|
Device: Battle Wrap TQ Tape 10 cm
Battle Wrap Tourniquet Tape is 10.16 cm (4 inch) in width. BW TQ 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 Name: BW10 TQ Tape
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02592655
Please refer to this study by its ClinicalTrials.gov identifier: NCT02592655
Locations
| United States, Ohio | |
| Vascular Medicine & Surgical Associates | |
| Youngstown, Ohio, United States, 44501 | |
Sponsors and Collaborators
Marcus Migura
Mercy Health
Investigators
| Principal Investigator: | Marcus W Migura | Unafiliated |
More Information
Additional Information:
Publications:
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.
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.
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
| Responsible Party: | Marcus Migura, Sponsor-Investigator, Migura, Marcus |
| ClinicalTrials.gov Identifier: | NCT02592655 History of Changes |
| Other Study ID Numbers: |
HCT001 |
| Study First Received: | October 27, 2015 |
| Last Updated: | January 13, 2016 |
Keywords provided by Marcus Migura, Migura, Marcus:
|
tourniquet arterial pre-hospital SOFTT-W Battle Wrap |
windlass exsanguination hemorrhage amputation |
Additional relevant MeSH terms:
|
Hemorrhage Vascular System Injuries Pathologic Processes |
Vascular Diseases Cardiovascular Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on July 13, 2017