Clinical trial NCT03492476: Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Arm
Keywords: Lymphedema of Upper Arm reduction
Lymphedema Upper Arm device
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: medi
First posted: 2018-04-10
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volume reduction of upper limb lymphatic edema D30
timeFrame: 30 days
Secondary outcomes:
measure: Volume reduction of upper limb lymphatic edema D5
timeFrame: 5 days
measure: Volume reduction of upper limb lymphatic edema D90
timeFrame: 90 days
measure: Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)
timeFrame: 5 days
measure: Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)
timeFrame: 5 days
measure: Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)
timeFrame: 30 days
measure: Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression)
timeFrame: 90 days
measure: Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression)
timeFrame: 30 days
measure: Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression)
timeFrame: 90 days
measure: Patient's satisfaction about efficiency of the treatment D30 (Likert scale)
timeFrame: 30 days
measure: Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale)
timeFrame: 30 days
measure: Patient's satisfaction about efficiency of the treatment D90 (Likert scale)
timeFrame: 30 days
measure: Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale)
timeFrame: 90 days
measure: Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient)
timeFrame: 30 days
measure: Tolerance of the different products (patient evaluation on self-administered questionnaire)
timeFrame: 90 days
measure: Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF)
timeFrame: 90 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Montpellier
country: France
facility: Chu Saint Eloi
city: Mulhouse
country: France
facility: Ghr Mulhouse Sud Alsace
city: Paris
country: France
facility: Hopital Cognacq Jay
Study officials:
affiliation: University Hospital, Montpellier
name: MARLENE COUPE, MD
role: STUDY_CHAIR
affiliation: medi France
name: ERIC MARTIN, M.
role: STUDY_DIRECTOR
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