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

Lymphedema of Upper Arm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492476
• Other study ID #: C1512
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: March 2, 2022

Study information

• Verified date: March 2023
• Source: CEN Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Arm

Intervention

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
• 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

Locations

Country	Name	City	State
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Chu Saint Eloi	Montpellier
France	Ghr Mulhouse Sud Alsace	Mulhouse
France	Hopital Cognacq Jay	Paris

Sponsors (2)

Lead Sponsor	Collaborator
CEN Biotech	medi

Country where clinical trial is conducted

France, 

References & Publications (12)

Campbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012 Apr 15;118(8 Suppl):2300-11. doi: 10.1002/cncr.27464. — View Citation

Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013 Feb;29(1):28-40. doi: 10.1016/j.soncn.2012.11.005. — View Citation

Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006

Grosclaude P, Remontet L, Belot A, Danzon A, Rasamimanana C, Bossard N. Survie des personnes atteintes de cancer en France, 1989-2007 - Etude à partir des registres des cancers du réseau Francim. Saint-Maurice: Institut de veille sanitaire; 2013. 412 p

Hayes SC, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema after breast cancer: incidence, risk factors, and effect on upper body function. J Clin Oncol. 2008 Jul 20;26(21):3536-42. doi: 10.1200/JCO.2007.14.4899. — View Citation

Leone N, Voirin N, Roche L, Binder-Foucard F, Woronoff AS, Delafosse P, Remontet L, Bossard N, Uhry Z. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Saint-Maurice (Fra): Institut de veille sanitaire, 2015. 62 p

Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012

Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24. — View Citation

Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12. — View Citation

Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009 Apr 20;27(12):2007-14. doi: 10.1200/JCO.2008.18.3517. Epub 2009 Mar 16. — View Citation

Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999 Mar;177(3):184-7; discussion 188. doi: 10.1016/s0002-9610(99)00008-2. — View Citation

Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer. 2011 Jul;19(7):935-40. doi: 10.1007/s00520-010-0906-x. Epub 2010 May 22. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume reduction of upper limb lymphatic edema D30	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	Volume reduction of upper limb lymphatic edema D5	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
Secondary	Volume reduction of upper limb lymphatic edema D90	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
Secondary	Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)	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
Secondary	Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)	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
Secondary	Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)	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
Secondary	Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression)	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
Secondary	Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression)	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
Secondary	Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression)	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
Secondary	Patient's satisfaction about efficiency of the treatment D30 (Likert scale)	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
Secondary	Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale)	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
Secondary	Patient's satisfaction about efficiency of the treatment D90 (Likert scale)	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
Secondary	Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale)	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
Secondary	Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient)	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
Secondary	Tolerance of the different products (patient evaluation on self-administered questionnaire)	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
Secondary	Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF)	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