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Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

NCT ID: NCT03584100

Last Updated: 2023-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2020-06-30

Brief Summary

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The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection

OUTLINE:

Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

PROCEDURE:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Conditions

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Healthy Subject

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients with prior axillary lymph node dissection

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Group Type EXPERIMENTAL

Tourniquet 8000

Intervention Type DEVICE

Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Healthy Volunteers

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Group Type ACTIVE_COMPARATOR

Tourniquet 8000

Intervention Type DEVICE

Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Interventions

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Tourniquet 8000

Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Intervention Type DEVICE

Other Intervention Names

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Pneumatic tourniquet

Eligibility Criteria

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Inclusion Criteria

* Have previously undergone axillary lymph node dissection
* Or healthy volunteers

Exclusion Criteria

* Have new-onset lymphedema of the involved limb.
* Infection including cellulitis
* Trauma or planned axillary surgery within 6 months of participation
* Any prior axillary radiation
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Yao, MD

Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Yao

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2018-01125

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRS0075

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-40228

Identifier Type: -

Identifier Source: org_study_id