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Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema

NCT03492476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-03-02

No results posted yet for this study

Summary

One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.

The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.

Conditions

  • Lymphedema of Upper Arm

Interventions

DEVICE

Circaid

Three observation periods were defined with the following products: * D1 to D5: intensive hospital treatment performed by the night and day wearing of the circaid® compression system * Day of Discharge (DD) from the hospital to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime compression system circaid® * DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime circaid® compression system

DEVICE

Short-stretching Bandage (Reference treatment)

Three observation periods were defined with the following products: * D1 to D5: intensive hospital treatment performed by the night and day wearing of short stretching tapes. * DD (Day of discharge from the hospital) to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with a possible treatment at night, as recommended by HAS. * DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with possible treatment at night

Sponsors & Collaborators

  • medi

    collaborator UNKNOWN

  • CEN Biotech

    lead INDUSTRY

Principal Investigators

  • MARLENE COUPE, MD · University Hospital, Montpellier

  • ERIC MARTIN, M. · medi France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2022-03-02
Completion
2022-03-02

Countries

  • France

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 NCT03492476 on ClinicalTrials.gov