Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage

Study Overview
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Brief Summary
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Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging. Secondary objectives: Assessment of safety Quality of life Health economic parameters Slippage Subbandage pressure

Official Title
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Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compression Therapy

Conditions
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Lymphedema

Intervention / Treatment
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* Device: 3M Coban 2 (Compression System)
* Device: 3M Coban 2 (Compression System)
* Device: 3M Coban 2 (Compression System)
* Device: Comprilan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Arm): Mobile males or females, age 18 years or older Unilateral arm lymphoedema of secondary origin Pitting arm lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging Patients who require intense bandaging therapy (approx. >= 15% increase in arm volume over the opposite healthy arm) Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation Willing to give written informed consent and willing to comply with the study protocol Inclusion Criteria (Leg): Mobile males or females, age 18 years or older Unilateral or bilateral leg lymphoedema of primary or secondary origin Pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging Patients who require intense bandaging therapy Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation Willing to give written informed consent and willing to comply with the study protocol Exclusion Criteria (Arm): Known pregnancy Evidence of active cancer, either local or metastatic A period of intense daily bandaging within the last month Decompensated heart failure or clinically relevant kidney or liver disease Known relevant arterial disease of the arms Deep vein thrombosis or phlebitis in the last 3 months Paralysis of the arms Clinical infection of the arms (e.g. erysipelas) Wounds located at the study arm that require dressing change more than once a week History of allergic reactions to study material Participation in any prospective clinical study that can potentially interfere with this study Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria. Exclusion Criteria (Leg): Known pregnancy Evidence of active cancer, either local or metastatic A period of intense daily bandaging within the last month Decompensated heart failure or clinically relevant kidney or liver disease Deep vein thrombosis or phlebitis in the last 3 months Known relevant arterial disease of the legs Paralysis of the legs Clinical infection of the legs (e.g. erysipelas) Circumferential Lymphorrhoea Wounds located at the study leg that require dressing change more than once a week History of allergic reactions to study material Participation in any prospective clinical study that can potentially interfere with this study Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - 3M Coban 2<br>3M Coban 2 - 2 apps/wk | Device: 3M Coban 2 (Compression System)<br>* Nonwoven cohesive backing and foam.<br>|
| Experimental: Arm 2 - 3M Coban 2<br>3M Coban 2 - 3 apps/wk | Device: 3M Coban 2 (Compression System)<br>* Nonwoven cohesive backing and foam.<br>|
| Experimental: Arm 3 - 3M Coban 2<br>Arm 3 - 3M Coban 2 - 5 apps/wk | Device: 3M Coban 2 (Compression System)<br>* Nonwoven cohesive backing and foam.<br>|
| Active Comparator: Arm 4 - Comprilan<br>Comprilan short-stretch bandage 5 apps/wk | Device: Comprilan<br>* Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. |  | baseline and after 3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Safety by Incidence of Adverse Events. |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoedema, lymphedema