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

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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

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


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.
We found this trial at
5
sites
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mi
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Evanston, IL
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Columbia, Missouri 65211
(573) 882-2121
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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mi
from
Columbia, MO
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Houston, Texas 77030
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mi
from
Houston, TX
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Milborne Port, Dorset
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mi
from
Milborne Port,
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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mi
from
Philadelphia, PA
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