Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
Status: | Completed |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/9/2018 |
Start Date: | March 2010 |
End Date: | October 2010 |
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
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
of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
- Assessment of safety
- Quality of life
- Health economic parameters
- Slippage
- Subbandage pressure
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.
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