Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
This study has been completed.
Sponsor:
3M
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01096589
First received: March 22, 2010
Last updated: January 20, 2012
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
Condition | Intervention |
---|---|
Lymphedema |
Device: 3M Oedema Reduction System (Compression Bandage) Device: Short-stretch Bandage (Comprilan; BSN Medical Ltd,). |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by 3M:
Primary Outcome Measures:
- Percent volume reduction of affected limb at end of treatment compared to baseline. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assessment of safety by incidence of adverse events. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Enrollment: | 84 |
Study Start Date: | March 2010 |
Study Completion Date: | October 2010 |
Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 - 3M Oedema Reduction System
3M Oedema Reduction System - 2 apps/wk
|
Device: 3M Oedema Reduction System (Compression Bandage)
Nonwoven cohesive backing and foam.
|
Experimental: Arm 2 - 3M Oedema Reduction System
3M Oedema Reduction System - 3 apps/wk
|
Device: 3M Oedema Reduction System (Compression Bandage)
Nonwoven cohesive backing and foam.
|
Experimental: Arm 3 - 3M Oedema Reduction System
3M Oedema Reduction System - 5 apps/wk
|
Device: 3M Oedema Reduction System (Compression Bandage)
Nonwoven cohesive backing and foam.
|
Active Comparator: Arm 4 - Commercial Compression System 5 apps/wk
Commercial Compression System 5 apps/wk
|
Device: Short-stretch Bandage (Comprilan; BSN Medical Ltd,).
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096589
Locations
United States, Illinois | |
NorthShore University Healthsystem | |
Evanston, Illinois, United States, 60201 | |
United States, Missouri | |
University of Missouri | |
Columbia, Missouri, United States, 65203 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Memorial Hermann Hyperbaric Center | |
Houston, Texas, United States, 77030 | |
United Kingdom | |
56 London Road Clinic | |
Milborne Port, Dorset, United Kingdom, DT9 5DW | |
Kendal Lymphology Centre | |
Kendal, United Kingdom, LA9 4BD | |
LOROS Hospice | |
Leicester, United Kingdom, LE3 9QE | |
St Giles Hospice Lymphoedema Service | |
Lichfield, United Kingdom, WS14 9LH | |
Enfield Macmillan Lymphoedema Service | |
London, United Kingdom, N9 7HD | |
St Oswalds Hospice Lymphoedema Clinic | |
Newcastle-upon-Tyne, United Kingdom, NE3 1EE | |
Swansea Lymphoedema Service Singleton Hospital | |
Swansea, United Kingdom, SA2 8QA |
Sponsors and Collaborators
3M
Investigators
Principal Investigator: | Christine Moffatt, Prof. | Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW |
More Information
No publications provided
Keywords provided by 3M:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | 3M |
ClinicalTrials.gov Identifier: | NCT01096589 History of Changes |
Other Study ID Numbers: | EU Study-05-000012 |
Study First Received: | March 22, 2010 |
Last Updated: | January 20, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by 3M:
lymphoedema lymphedema |
Additional relevant MeSH terms:
Lymphedema Lymphatic Diseases |
ClinicalTrials.gov processed this record on October 17, 2012