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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592655
• Other study ID #: HCT001
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: August 22, 2017
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Migura, Marcus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Vascular Injury
• Vascular System Injuries

Intervention

Device:
• Pneumatic Tourniquet
Automated pneumatic tourniquet, applied to middle upper thigh.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Vascular Medicine & Surgical Associates	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Marcus Migura	Mercy Health

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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.

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. — View Citation

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. — View 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

External Links

•   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
•   USAISR Technical Report No. 2005-05 Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers