A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
Randomized Sequence, Assessor-Blind, Cross-Over Study of a Windlass Tourniquet, a Pneumatic Tourniquet and an Elastic Adhesive Bandage for Use as a Tourniquet
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
August 24, 2017
CompletedAugust 24, 2017
January 1, 2016
Same day
October 27, 2015
January 10, 2017
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiologist Limb Occlusion Assessment
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor. The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist.
For 1 sustained minute after application of each tourniquet intervention.
Investigator Limb Occlusion Assessment
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.
For 1 sustained minute after application of each tourniquet intervention.
Study Arms (4)
Pneumatic Tourniquet
ACTIVE COMPARATORAll participants randomly allocated to receive all interventions. Pneumatic Tourniquet: 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. The 10 cm (4 inch) wide cylindrical cuff was used for all participants.
Windlass Tourniquet
ACTIVE COMPARATORWindlass Tourniquet with a 3.8 cm (1.5 inch) wide strap is representative of the typical use device in civilian prehospital and military combat environments. In accordance with current prehospital guidelines: If distal perfusion is observed after One Windlass Tourniquet is applied then a second windlass tourniquet will be applied immediately proximal to the first windlass tourniquet so that the participant has Two Windlass Tourniquets applied.
Tourniquet Tape 10 cm
EXPERIMENTALTourniquet Tape 10 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself.
Tourniquet Tape 5 cm
EXPERIMENTALTourniquet Tape 5 cm wide is a highly elastic transparent occlusive tape that is expected to create sufficient circumferential pressure to occlude arterial blood flow when tightly wrapped around a limb. The tape should be applied in mostly overlapping layers. The final wrap should be applied without tension to prevent the elastic tension from causing the tape to unwind itself.
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.
Eligibility Criteria
You may qualify if:
- Upper thigh circumference greater than 61 cm or 24 inches.
- Upper thigh circumference greater than the 50th percentile based on available anthropometric data.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcus Miguralead
- Mercy Healthcollaborator
Study Sites (1)
Vascular Medicine & Surgical Associates
Youngstown, Ohio, 44501, United States
Related Publications (10)
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.
PMID: 22128650BACKGROUNDWenke 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.
PMID: 16261983BACKGROUNDTaylor DM, Vater GM, Parker PJ. An evaluation of two tourniquet systems for the control of prehospital lower limb hemorrhage. J Trauma. 2011 Sep;71(3):591-5. doi: 10.1097/TA.0b013e31820e0e41.
PMID: 21768905BACKGROUNDSwan 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.
PMID: 19276736BACKGROUNDKing 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.
PMID: 16688072BACKGROUNDWalters 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.
PMID: 16261982BACKGROUNDWalters 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.
PMID: 16263675BACKGROUNDRuterbusch 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.
BACKGROUNDHill 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.
BACKGROUNDThomas 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Tourniquet tape 5 cm ended early due to excessive narrowing, resulting in data loss. The pressure mapping system proved subjective in use and software bugs resulted corrupt data files. Small sample size, therefore only large individuals enrolled.
Results Point of Contact
- Title
- Marcus Migura
- Organization
- Marcus Migura
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus W Migura
Unafiliated
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 30, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 24, 2017
Results First Posted
August 24, 2017
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF, CSR
- Time Frame
- Upon publication of summary results. Web links are provided in the references section.
- Access Criteria
- De-identified IPD from this study will be public domain. Identifying information and records will be held confidential.
Individual participant data will be de-identified and consolidated into one Excel file and made available online. Still ultrasound images used for primary outcome assessment will be consolidated into one pdf and made available online. Individual participant data that is not supported by clinicaltrials.gov will be posted with Zenodo or by other means. The intent to release de-identified data was disclosed to each volunteer during the informed consent process.