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Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)

NCT02167659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1201

Last updated 2021-01-11

No results posted yet for this study

Summary

Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥6.5 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is between ≥ 5% and \<10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.

Conditions

  • Lymphedema

Interventions

DEVICE

23-32 mmHg compression sleeve with gauntlet

A compression intervention consisting of a sleeve and gauntlet with 23-32mm of tension worn for four weeks that is initiated based on a BIS L-Dex change that is ≥6.5 units higher than pre-surgical baseline measure, or a tape measurement guided volume change in the affected arm that is between ≥5% and \<10% above pre-surgical baseline.

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • Macquarie University, Australia

    collaborator OTHER

  • ImpediMed Limited

    lead INDUSTRY

Principal Investigators

  • Sheila H Ridner, PhD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167659 on ClinicalTrials.gov