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

October 10, 2018 updated by: 3M

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Kendal, United Kingdom, LA9 4BD
        • Kendal Lymphology Centre
      • Leicester, United Kingdom, LE3 9QE
        • LOROS Hospice
      • Lichfield, United Kingdom, WS14 9LH
        • St Giles Hospice Lymphoedema Service
      • London, United Kingdom, N9 7HD
        • Enfield Macmillan Lymphoedema Service
      • Newcastle-upon-Tyne, United Kingdom, NE3 1EE
        • St Oswalds Hospice Lymphoedema Clinic
      • Swansea, United Kingdom, SA2 8QA
        • Swansea Lymphoedema Service Singleton Hospital
    • Dorset
      • Milborne Port, Dorset, United Kingdom, DT9 5DW
        • 56 London Road Clinic
  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hyperbaric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - 3M Coban 2
3M Coban 2 - 2 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Experimental: Arm 2 - 3M Coban 2
3M Coban 2 - 3 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Experimental: Arm 3 - 3M Coban 2
Arm 3 - 3M Coban 2 - 5 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Active Comparator: Arm 4 - Comprilan
Comprilan short-stretch bandage 5 apps/wk
Device: Comprilan
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Time Frame: baseline and after 3 weeks of treatment
baseline and after 3 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of Safety by Incidence of Adverse Events.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

  • Principal Investigator: Christine Moffatt, Prof., Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU Study-05-000012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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