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

March 1, 2023 updated by: CEN Biotech

Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the intensive decongestive treatment phase, which usually takes place in specialized lymphedema treatment departments, the staff are properly trained and have the required experience, but the appliance of these short-length compression bandages requires a lot of time. During the maintenance phase, the appliance of short stretch bandages gives way during the day to the wearing of a compression sleeve which can be put on fairly easily. But during the night, in the absence of a nurse or a spouse with the technical skills required to put them in place, few patients can benefit from the wearing of short stretching bandages. During the maintenance phase, many patients quickly give up these nocturnal bandages, thus losing the gain obtained during the reduction phase. This situation is all the more regrettable that, as shown in the studies, this nocturnal wearing contributes to a very significant reduction in the rate of reappearance of lymphedema and avoids the recurrent need of intensive reduction sessions in hospitals, which are costly for health insurance. and uncomfortable for the patients.

To improve this situation, medi has developed a device called circaid®, consisting of non-elastic bands adjustable and repositionable with "Velcro" systems, which can be used both for the intensive reduction phase but also during the maintenance phase by the patients themselves because of its ease of placement.

It is composed of several inelastic strips or removable straps, parallel and overlapping slightly to leave no crease and no space between them. Velcro tabs or fasteners help ensure proper initial positioning and readjustment as the arm volume is reduced. This gives a given pressure by tightening or loosening each band while limiting friction and discomfort. In the intensive reduction phase, its ease of use reduces the time devoted by nurses to the use of short stretching tapes which, in addition to the need for good technique, requires a significant amount of time. In the maintenance phase, this original and comfortable compression device allows the patient to become autonomous after minimal learning. The simplicity of the introduction of the system on the limb and the calibration of the delivered pressure allows to develop the self management of the treatment, because it is possible to reposition the bands as and when the decrease of the edema, which makes it possible to optimize the effectiveness of the treatment. The ability to instantly readjust the circaid®Juxtafit system allows to constantly apply the right level of pressure delivered, to reduce the volume of the limb. This is not possible with a traditional multilayer bandage if the different layers are not completely remove. A visual calibrator ensures the right level of pressure delivered at all times.

In addition to efficiency, patients' quality of life is improved by being able to remove and return it on their own, making it easier to wash or dress. Similarly, less rigid while being just as compressive, it allows a better comfort in the daily gestures and in particular to have a normal range of arm flexion movements more compatible with driving than the wearing of tapes.

The product is currently marketed in many countries and is reimbursed in the following countries: United States, Quebec, the Netherlands, United Kingdom, Austria in the indication of the treatment of lymphedema.

In view of its admission to reimbursement in France, a meeting was held with HAS experts in the context of the so-called early meeting procedure in order to define the study that should be done. A detailed synopsis which is the one of the present protocol has been validated by the methodological experts of the HAS as being able to bring the arguments of effectiveness required by being as close as possible to the usual practice and by covering at the same time the phase of intensive reduction and the maintenance phase. It 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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Montpellier, France, 34295
        • CHU Saint Eloi
      • Mulhouse, France, 68070
        • Ghr Mulhouse Sud Alsace
      • Paris, France, 75015
        • Hopital Cognacq Jay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • be women over the age of 18;
  • presenting a unilateral lymphedema of the upper limb of stage II or III according to the International Society of Lymphology, secondary to the curative ganglion treatment of a cancer, whatever its nature, and requiring a decongestive treatment by contention / compression;
  • presenting an increase in the volume of the arm affected by lymphedema of at least 10% when compared to the contralateral arm;
  • benefiting of the French health insurance coverage;
  • duly informed of the benefits, constraints and risks of the study;
  • medically and legally able to understand the methods of carrying out the study and to give written informed consent to participate in the study;
  • having given their free written informed consent to their participation in the study

Exclusion Criteria:

Not be included in the study:

  • from a medical point of view, the patients:

    • with stage I lymphedema;
    • with lymphedema of multiple locations;
    • having had intensive decongestive treatment in the last 6 months;
    • having a recurrence of cancer or a peripheral arterial disease contraindicating or restraining compression.

  • from a legal point of view, the patients:

    • not in a position to give free and informed consent because of an administrative or judicial decision or a pathology that may affect their judgment or a difficulty of linguistic comprehension;
    • currently participating in another clinical trial or in an exclusion period from another clinical trial;
    • who may not adhere to the terms of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Circaid
Compression sleeve on the day associated with the night wearing of the system of contention circaid®
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
Other Names:
  • Non-elastic bands
Active Comparator: Reference treatment
Compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the HAS
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
Other Names:
  • Non-elastic bands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume reduction of upper limb lymphatic edema D30
Time Frame: 30 days
The main objective of the study is to compare, at the 30th day of the initial maintenance phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the wearing of a compression sleeve on the day associated with the night wearing of the system of contention circaid® versus the wearing of a compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the french High Authority of Health (HAS).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume reduction of upper limb lymphatic edema D5
Time Frame: 5 days
To compare, on the 5th day of the reduction phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the night and day wearing of the circaid® compression system and the night and day wearing of short lengthening bands such as recommended by the HAS
5 days
Volume reduction of upper limb lymphatic edema D90
Time Frame: 90 days
To compare, at the 90th day of the maintenance phase, the reduction in the volume of lymphatic edema maintained by the wearing of a compression sleeve during the day associated with the circaid® compression system at night and the wearing of a compression sleeve during the day associated with a possible wearing at night.
90 days
Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)
Time Frame: 5 days
To compare, at the 5th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the Clinical Global Improvement Impression (CGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
5 days
Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)
Time Frame: 5 days
To compare, at the 5th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the Patient Global Improvement Impression (PGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
5 days
Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)
Time Frame: 30 days
To compare, at the 30th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
30 days
Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression)
Time Frame: 90 days
To compare, at the 90th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
90 days
Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression)
Time Frame: 30 days
To compare, at the 30th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
30 days
Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression)
Time Frame: 90 days
To compare, at the 90th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
90 days
Patient's satisfaction about efficiency of the treatment D30 (Likert scale)
Time Frame: 30 days
To compare, at the 30th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".
30 days
Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale)
Time Frame: 30 days
To compare, at the 30th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".
30 days
Patient's satisfaction about efficiency of the treatment D90 (Likert scale)
Time Frame: 30 days
To compare, at the 90th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".
30 days
Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale)
Time Frame: 90 days
To compare, at the 90th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".
90 days
Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient)
Time Frame: 30 days
To compare, at the 90th day of the initial maintenance phase the patients' opinions on the ease of use of the product. The patient have to complete 6 items (Yes/no response) : "Did you need caregiver's help ?"; "Did you need a third party to install the device ?"; "Did you have difficulty applying the required pressures ?"; "Do you wish to continue using the device ?"; "Would you recommend this device to third parties ?"; "Does the device seem easy to use ?".
30 days
Tolerance of the different products (patient evaluation on self-administered questionnaire)
Time Frame: 90 days
To compare the tolerance of the different products at different phases of reduction and maintenance. Evaluation item on patient self-administered questionnaire "Intolerance to the device" to be assessed every week (Yes/no response, if yes, the patient have to precise).
90 days
Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF)
Time Frame: 90 days
The quality of patient's life is assessed at each visit (D0, D5, D30, D90) with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF).
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEN Biotech

Collaborators

medi

Investigators

  • Study Chair: MARLENE COUPE, MD, University Hospital, Montpellier
  • Study Director: ERIC MARTIN, M., medi France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2017

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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