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

Lymphedema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096589
• Other study ID #: EU Study-05-000012
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2018
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
• 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
• 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
• Comprilan
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Locations

Country	Name	City	State
United Kingdom	Kendal Lymphology Centre	Kendal
United Kingdom	LOROS Hospice	Leicester
United Kingdom	St Giles Hospice Lymphoedema Service	Lichfield
United Kingdom	Enfield Macmillan Lymphoedema Service	London
United Kingdom	56 London Road Clinic	Milborne Port	Dorset
United Kingdom	St Oswalds Hospice Lymphoedema Clinic	Newcastle-upon-Tyne
United Kingdom	Swansea Lymphoedema Service Singleton Hospital	Swansea
United States	University of Missouri	Columbia	Missouri
United States	NorthShore University Healthsystem	Evanston	Illinois
United States	Memorial Hermann Hyperbaric Center	Houston	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
3M

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.		baseline and after 3 weeks of treatment
Secondary	Assessment of Safety by Incidence of Adverse Events.		3 weeks