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

Solventum US LLC

Status: Completed

Conditions: Lymphedema

Treatments: Device: 3M Coban 2 (Compression System); Device: Comprilan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096589

EU Study-05-000012

Details and patient eligibility

About

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

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Arm 1 - 3M Coban 2

Experimental group

Description:

3M Coban 2 - 2 apps/wk

Treatment:

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Arm 2 - 3M Coban 2

Experimental group

Description:

3M Coban 2 - 3 apps/wk

Treatment:

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Arm 3 - 3M Coban 2

Experimental group

Description:

Arm 3 - 3M Coban 2 - 5 apps/wk

Treatment:

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Device: 3M Coban 2 (Compression System)

Arm 4 - Comprilan

Active Comparator group

Description:

Comprilan short-stretch bandage 5 apps/wk

Treatment:

Device: Comprilan