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

Launched by SOLVENTUM US LLC · Mar 30, 2010

Keywords

ClinConnect Summary

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Gender

ALL

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.