A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet

• Sponsor: Marcus Migura (Other)
• Overall Status: Completed
• CT.gov ID: NCT02592655
• Collaborator: Mercy Health (Other)
• Enrollment: 19
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage; Vascular Injury	Device: Pneumatic Tourniquet; Device: One Windlass Tourniquet; Device: Two Windlass Tourniquets; Device: Tourniquet Tape 5 cm; Device: Tourniquet Tape 10 cm	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (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
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pneumatic Tourniquet All 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.	Device: Pneumatic Tourniquet; Automated pneumatic tourniquet, applied to middle upper thigh.; Other Names: Zimmer Automatic Tourniquet System (ATS) 1500
Active Comparator: Windlass Tourniquet Windlass 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.	Device: One Windlass Tourniquet; 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.; Other Names: Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) ; Device: Two Windlass Tourniquets; 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.
Experimental: Tourniquet Tape 10 cm Tourniquet 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.	Device: Tourniquet Tape 5 cm; 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.
Experimental: Tourniquet Tape 5 cm Tourniquet 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.	Device: Tourniquet Tape 10 cm; 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.

Outcome Measures

Primary Outcome Measures

1. Radiologist Limb Occlusion Assessment [For 1 sustained minute after application of each tourniquet intervention.]

   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.

2. Investigator Limb Occlusion Assessment [For 1 sustained minute after application of each tourniquet intervention.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Medicine & Surgical Associates	Youngstown	Ohio	United States	44501

Sponsors and Collaborators

• Marcus Migura
• Mercy Health

Investigators

• Principal Investigator: Marcus W Migura, Unafiliated

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NEDU Technical Report No.05-15 Archive Evaluation of Self-Applied Tourniquets for Combat Applications 2005
• NEDU Technical Report No.07-07 Archive Evaluation of Self-Applied Tourniquets for Combat Applications, Second Phase 2007

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Taylor 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.
• 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
• Walters TJ, Mabry RL. Issues related to the use of tourniquets on the battlefield. Mil Med. 2005 Sep;170(9):770-5.
• 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.
• 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.

• Responsible Party: Marcus Migura, Sponsor-Investigator, Migura, Marcus
• ClinicalTrials.gov Identifier: NCT02592655
• Other Study ID Numbers: HCT001
• First Posted: Oct 30, 2015
• Last Update Posted: Aug 24, 2017
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Marcus Migura, Sponsor-Investigator, Migura, Marcus: tourniquet; arterial; pre-hospital; SOFTT-W; Battle Wrap; windlass; exsanguination; hemorrhage; amputation
• Additional relevant MeSH terms: Vascular System Injuries; Hemorrhage

Study Results

Participant Flow

Recruitment Details	Healthy volunteers with a minimum upper thigh circumference of 61 cm were recruited from the general population during the first two weeks of December 2015.
Pre-assignment Detail	Each participant receives a different intervention each period. 19 Participants randomly allocated to unique sequences of four interventions. No participants were lost once enrolled. 5 minute minimum washout period between interventions.

Arm/Group Title	All Participants
Arm/Group Description	Each subject has been randomly allocated to a sequence of interventions. Pneumatic tourniquet with a 10 cm (4 inch) wide cylindrical cuff typically used in surgical settings, and is representative of best outcome. Windlass Tourniquet: The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.8 cm (1.5 inch) in width. The SOFTT-W is representative of the typical emergency tourniquet. In accordance with current prehospital guidelines: If a single windlass tourniquet not effective then a second windlass tourniquet will be applied immediately proximal to the first. Tourniquet Tape 10 cm wide and Tourniquet Tape 5 cm wide are elastic adhesive tape tourniquets. 5 cm tape was discontinued after the 4th participant. Once stretched the tape was too narrow for sufficient overlap. Because the overlap was not sufficient the edges began to roll. This would create an unacceptably narrow band if left in place longer than the prescribed time.
Period Title: First Tourniquet, Left Thigh.
STARTED	19
ATS (Pneumatic)	5
Windlass Tourniquet	7
Tourniquet Tape 10 cm Width	5
Tourniquet Tape 5 cm Width	2
COMPLETED	19
NOT COMPLETED	0
Period Title: First Tourniquet, Left Thigh.
STARTED	19
ATS (Pneumatic)	5
Windlass Tourniquet	8
Tourniquet Tape 10 cm Width	5
Tourniquet Tape 5 cm Width	1
COMPLETED	19
NOT COMPLETED	0
Period Title: First Tourniquet, Left Thigh.
STARTED	19
ATS (Pneumatic)	8
Windlass Tourniquet	4
Tourniquet Tape 10 cm Width	6
Tourniquet Tape 5 cm Width	1
COMPLETED	19
NOT COMPLETED	0
Period Title: First Tourniquet, Left Thigh.
STARTED	4
ATS (Pneumatic)	1
Windlass Tourniquet	0
Tourniquet Tape 10 cm Width	3
Tourniquet Tape 5 cm Width	0
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	One Windlass Tourniquet	Two Windlass Tourniquets	Total
Arm/Group Description	Baseline characteristics for participants that received only one windlass tourniquet.	Baseline characteristics for participants who had a second windlass tourniquet applied immediately proximal to the first. Meaning that a single windlass tourniquet did not appear effective.	Total of all reporting groups
Overall Participants	8	11	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.5 (9.5)	36.1 (8.8)	33.7 (9.25)
Sex: Female, Male (Count of Participants)
Female	0 0%	4 36.4%	4 21.1%
Male	8 100%	7 63.6%	15 78.9%
Body Mass Index (BMI) (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	27.4 (1.7)	36.1 (4.3)	32.4 (5.6)
BMI Weight Status Category (CDC) (Count of Participants)
BMI 18.5 - 24.9 Normal	1 12.5%	0 0%	1 5.3%
BMI 25.0 - 29.9 Overweight	7 87.5%	1 9.1%	8 42.1%
BMI 30.0 and Above Obese	0 0%	10 90.9%	10 52.6%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	87.5 (11.0)	111.3 (21.5)	101.25 (21.22)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	178.6 (9.7)	175.0 (10.1)	176.5 (9.8)
Thigh Circumference (cm) [Mean (Standard Deviation) ]
Upper Thigh	63.5 (3.7)	71.2 (5.9)	68.0 (6.3)
10 cm above Mid Thigh	61.0 (4.0)	68.7 (5.7)	65.4 (6.3)
Middle Thigh	55 (4.2)	60.3 (5.3)	58.1 (5.5)
Lower Thigh	42.3 (4.4)	45.8 (3.1)	44.3 (4.0)
Percentile of Mean Thigh Circumference (Percentile) [Number]
Upper thigh circumference percentile	65	95	90
Lower thigh circumference percentile	75	95	90
Systolic Blood Pressure (SBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	130 (8.8)	136 (10.4)	133 (10.0)
Limb Occlusion Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	280 (30)	319 (44)	302 (43)
Ankle Brachial Index (ABI) (Ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Ratio]	1.15 (0.08)	1.16 (0.11)	1.16 (0.09)

Outcome Measures

1. Primary Outcome

Title	Radiologist Limb Occlusion Assessment
Description	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.
Time Frame	For 1 sustained minute after application of each tourniquet intervention.

Outcome Measure Data

Analysis Population Description

One ultrasound image from one of the participants of the pneumatic tourniquet (ATS) group failed to capture anatomy and was therefore not included in the analysis. One ultrasound image from one of the participants of the windlass tourniquet (SOFTT-W) group failed to capture anatomy and was therefore not included in the analysis.

Arm/Group Title	Tourniquet Tape 10 cm	Pneumatic Tourniquet	One Windlass Tourniquet	Two Windlass Tourniquets
Arm/Group Description	Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.	Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.	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 one windlass tourniquet 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.	Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets 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.
Measure Participants	19	18	18	10
Success: Absent flow verified by radiologist.	19 237.5%	18 163.6%	8 42.1%	8 NaN
Failure: Flow verified by radiologist.	0 0%	0 0%	10 52.6%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tourniquet Tape 10 cm, One Windlass Tourniquet
	Comments	Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape. Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Significance thresh hold: 0.05.
	Method	McNemar
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	One Windlass Tourniquet, Two Windlass Tourniquets
	Comments	Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets. Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments	Significance thresh hold: 0.05.
	Method	McNemar
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tourniquet Tape 10 cm, Two Windlass Tourniquets
	Comments	Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets. Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments	Significance thresh hold: 0.05.
	Method	McNemar
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pneumatic Tourniquet, Two Windlass Tourniquets
	Comments	Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets. Participant count of 17 to accommodate for missing ultrasound data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments	Significance thresh hold: 0.05.
	Method	McNemar
	Comments

2. Primary Outcome

Title	Investigator Limb Occlusion Assessment
Description	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.
Time Frame	For 1 sustained minute after application of each tourniquet intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tourniquet Tape 10 cm	Pneumatic Tourniquet	One Windlass Tourniquet	Two Windlass Tourniquets	Tourniquet Tape 5 cm
Arm/Group Description	Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.	Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.	Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of one windlass tourniquet to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.	Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of the two windlass tourniquets to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.	Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
Measure Participants	19	19	19	11	4
Success: Absent flow observed by investigator.	19 237.5%	19 172.7%	8 42.1%	9 NaN	3 NaN
Failure: Flow observed by investigator.	0 0%	0 0%	11 57.9%	2 NaN	1 NaN

Adverse Events

Time Frame	1 day
Arm/Group Title	Pneumatic Tourniquet		Windlass Tourniquet		Tourniquet Tape 5 cm		Tourniquet Tape 10 cm
Arm/Group Description	The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) was used with a 10 cm (4 inch) wide pneumatic cuff.		One or two windlass tourniquets applied as needed to achieve study objectives.		Tourniquet Tape 5 cm (2 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.		Tourniquet Tape, 10 cm (4 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
All Cause Mortality
	Pneumatic Tourniquet		Windlass Tourniquet		Tourniquet Tape 5 cm		Tourniquet Tape 10 cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/4 (0%)		0/19 (0%)
Serious Adverse Events
	Pneumatic Tourniquet		Windlass Tourniquet		Tourniquet Tape 5 cm		Tourniquet Tape 10 cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/4 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Pneumatic Tourniquet		Windlass Tourniquet		Tourniquet Tape 5 cm		Tourniquet Tape 10 cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/4 (0%)		0/19 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.