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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 - 3M Coban 2

3M Coban 2 - 2 apps/wk

Group Type EXPERIMENTAL

3M Coban 2 (Compression System)

Intervention Type DEVICE

Nonwoven cohesive backing and foam.

Arm 2 - 3M Coban 2

3M Coban 2 - 3 apps/wk

Group Type EXPERIMENTAL

3M Coban 2 (Compression System)

Intervention Type DEVICE

Nonwoven cohesive backing and foam.

Arm 3 - 3M Coban 2

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

Group Type EXPERIMENTAL

3M Coban 2 (Compression System)

Intervention Type DEVICE

Nonwoven cohesive backing and foam.

Arm 4 - Comprilan

Comprilan short-stretch bandage 5 apps/wk

Group Type ACTIVE_COMPARATOR

Comprilan

Intervention Type DEVICE

Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Interventions

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3M Coban 2 (Compression System)

Nonwoven cohesive backing and foam.

Intervention Type DEVICE

3M Coban 2 (Compression System)

Nonwoven cohesive backing and foam.

Intervention Type DEVICE

3M Coban 2 (Compression System)

Nonwoven cohesive backing and foam.

Intervention Type DEVICE

Comprilan

Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No