assessment of 3m oedema reduction system in the treatment of lymphoedema compared to commercial short-stretch bandage

Conditions: Lymphedema

Summary: 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


Eligibility criteria:
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.

Keywords: lymphoedema lymphedema