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

NCT ID: NCT02592655

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Hemorrhage; Vascular Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pneumatic Tourniquet

Intervention Type: DEVICE

Automated pneumatic tourniquet, applied to middle upper thigh.

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.

Group Type: ACTIVE_COMPARATOR

One Windlass Tourniquet

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

Tourniquet Tape 5 cm

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

Tourniquet Tape 10 cm

Intervention Type: DEVICE

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.

Interventions

Pneumatic Tourniquet

Automated pneumatic tourniquet, applied to middle upper thigh.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Zimmer Automatic Tourniquet System (ATS) 1500; Special Operations Forces Tactical Tourniquet Wide (SOFTT-W)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mercy Health

OTHER

Sponsor Role: collaborator

Marcus Migura

INDIV

Sponsor Role: lead

Responsible Party

Marcus Migura

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marcus W Migura

Role: PRINCIPAL_INVESTIGATOR

Unafiliated

Locations

Vascular Medicine & Surgical Associates

Youngstown, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22128650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16261983 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21768905 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19276736 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16688072 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16261982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16263675 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Study Documents

Document Type: Primary Outcome Ultrasound Images

NCT02592655 Primary Outcome Tourniquet Study

View Document

Document Type: Individual Participant Data Set

NCT02592655 Individual level data set

View Document

Document Type: Informed Consent Form

Informed consent form containing description of study and procedures.

View Document

Other Identifiers

HCT001

Identifier Type: -

Identifier Source: org_study_id