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

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01096589
• Collaborator: (none)
• Enrollment: 82
• Locations: 11
• Arms: 4
• Duration (Months): 7
• Patients Per Site: 7.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Lymphedema	Device: 3M Coban 2 (Compression System); Device: 3M Coban 2 (Compression System); Device: 3M Coban 2 (Compression System); Device: Comprilan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. [baseline and after 3 weeks of treatment]

Secondary Outcome Measures

1. Assessment of Safety by Incidence of Adverse Events. [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University Healthsystem	Evanston	Illinois	United States	60201
2	University of Missouri	Columbia	Missouri	United States	65203
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	Memorial Hermann Hyperbaric Center	Houston	Texas	United States	77030
5	56 London Road Clinic	Milborne Port	Dorset	United Kingdom	DT9 5DW
6	Kendal Lymphology Centre	Kendal		United Kingdom	LA9 4BD
7	LOROS Hospice	Leicester		United Kingdom	LE3 9QE
8	St Giles Hospice Lymphoedema Service	Lichfield		United Kingdom	WS14 9LH
9	Enfield Macmillan Lymphoedema Service	London		United Kingdom	N9 7HD
10	St Oswalds Hospice Lymphoedema Clinic	Newcastle-upon-Tyne		United Kingdom	NE3 1EE
11	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT01096589
• Other Study ID Numbers: EU Study-05-000012
• First Posted: Mar 31, 2010
• Last Update Posted: Nov 7, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by 3M: lymphoedema; lymphedema
• Additional relevant MeSH terms: Lymphedema; Monensin

Study Results

Participant Flow

Recruitment Details	Participants were randomly allocated to the 4 application frequencies for 19 days. The randomisation was stratified according to limb location. Enroled participants were randomly assigned to one of the four treatment groups. Patients were treated in private lymphoedema clinics or in NHS centres (UK). US patients were treated in hospitals.

Arm/Group Title	Arm 1 - 3M Oedema Reduction System	Arm 2 - 3M Oedema Reduction System	Arm 3 - 3M Oedema Reduction System	Arm 4 - Commercial Compression System 5 Apps/wk
Arm/Group Description	3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
Period Title: Overall Study
STARTED	22	20	22	18
COMPLETED	18	18	18	15
NOT COMPLETED	4	2	4	3

Baseline Characteristics

Arm/Group Title	Arm 1 - 3M Oedema Reduction System	Arm 2 - 3M Oedema Reduction System	Arm 3 - 3M Oedema Reduction System	Arm 4 - Commercial Compression System 5 Apps/wk	Total
Arm/Group Description	3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).	Total of all reporting groups
Overall Participants	22	20	22	18	82
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	15 68.2%	9 45%	11 50%	14 77.8%	49 59.8%
>=65 years	7 31.8%	11 55%	11 50%	4 22.2%	33 40.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.73 (13.29)	61.85 (14.49)	62.27 (13.25)	56.22 (14.78)	60.16 (13.85)
Sex: Female, Male (Count of Participants)
Female	20 90.9%	20 100%	20 90.9%	17 94.4%	77 93.9%
Male	2 9.1%	0 0%	2 9.1%	1 5.6%	5 6.1%
Region of Enrollment (participants) [Number]
United States	5 22.7%	3 15%	2 9.1%	2 11.1%	12 14.6%
United Kingdom	17 77.3%	17 85%	20 90.9%	16 88.9%	70 85.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients must have completed the first week.

Arm/Group Title	Arm 1 - 3M Oedema Reduction System	Arm 2 - 3M Oedema Reduction System	Arm 3 - 3M Oedema Reduction System	Arm 4 - Commercial Compression System 5 Apps/wk
Arm/Group Description	3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.	Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
Measure Participants	18	20	22	16
Mean (Standard Deviation) [% volume change measured in mL.]	-14.56 (12.22)	-7.09 (7.30)	-10.24 (8.65)	-9.84 (4.34)

2. Secondary Outcome

Title	Assessment of Safety by Incidence of Adverse Events.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - 3M Coban 2	Arm 2 - 3M Coban 2	Arm 3 - 3M Coban 2	Arm 4 - Comprilan
Arm/Group Description	3M Coban 2 - 2 apps/wk 3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.	3M Coban 2 - 3 apps/wk 3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.	Arm 3 - 3M Coban 2 - 5 apps/wk 3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.	Comprilan short-stretch bandage 5 apps/wk Comprilan: Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
Measure Participants	22	20	22	18
Number [No. of treatment-emergent adverse events]	13	11	14	10

Adverse Events

Arm/Group Title	Arm 1 - 3M Oedema Reduction System		Arm 2 - 3M Oedema Reduction System		Arm 3 - 3M Oedema Reduction System		Arm 4 - Commercial Compression System 5 Apps/wk
Arm/Group Description	3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.		3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.		3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.		Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
All Cause Mortality
	Arm 1 - 3M Oedema Reduction System		Arm 2 - 3M Oedema Reduction System		Arm 3 - 3M Oedema Reduction System		Arm 4 - Commercial Compression System 5 Apps/wk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 - 3M Oedema Reduction System		Arm 2 - 3M Oedema Reduction System		Arm 3 - 3M Oedema Reduction System		Arm 4 - Commercial Compression System 5 Apps/wk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)		0/22 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - 3M Oedema Reduction System		Arm 2 - 3M Oedema Reduction System		Arm 3 - 3M Oedema Reduction System		Arm 4 - Commercial Compression System 5 Apps/wk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/22 (59.1%)		11/20 (55%)		14/22 (63.6%)		10/18 (55.6%)
Gastrointestinal disorders
Food poisoning	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Nausea	0/22 (0%)	0	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Gastric disorder	0/22 (0%)	0	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
General disorders
Medical device discomfort	2/22 (9.1%)	2	3/20 (15%)	5	2/22 (9.1%)	4	3/18 (16.7%)	6
Application site discomfort	0/22 (0%)	0	1/20 (5%)	1	4/22 (18.2%)	5	2/18 (11.1%)	3
Application site irritation	0/22 (0%)	0	2/20 (10%)	2	0/22 (0%)	0	0/18 (0%)	0
Application site reaction	1/22 (4.5%)	1	1/20 (5%)	1	1/22 (4.5%)	1	1/18 (5.6%)	1
Application site erythema	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Application site paraethesia	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Application site swelling	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Discomfort	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Fibrosis	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Generalised oedema	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
oedema peripheral	0/22 (0%)	0	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Application site vesicles	1/22 (4.5%)	1	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Malaise	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Infections and infestations
Folliculitis	1/22 (4.5%)	2	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Gastroenteritis	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Clellulitis	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Injury, poisoning and procedural complications
Joint sprain	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Open wound	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Excoriation	1/22 (4.5%)	1	0/20 (0%)	0	1/22 (4.5%)	1	1/18 (5.6%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity	2/22 (9.1%)	2	2/20 (10%)	4	0/22 (0%)	0	1/18 (5.6%)	1
Limb discomfort	1/22 (4.5%)	1	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Musculoskeletal discomfort	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Musculoskeletal pain	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Musculoskeletal stiffness	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Osteoarthritis	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Rheumatoid arthritis	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Joint swelling	0/22 (0%)	0	1/20 (5%)	1	1/22 (4.5%)	1	0/18 (0%)	0
Arthralgia	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Back pain	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Nervous system disorders
Hypoaesthesia	0/22 (0%)	0	1/20 (5%)	2	0/22 (0%)	0	0/18 (0%)	0
Neuralgia	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Psychiatric disorders
Anxiety	0/22 (0%)	0	0/20 (0%)	0	1/22 (4.5%)	1	0/18 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Skin and subcutaneous tissue disorders
Skin irritation	3/22 (13.6%)	4	1/20 (5%)	3	0/22 (0%)	0	1/18 (5.6%)	1
Erythema	1/22 (4.5%)	1	2/20 (10%)	4	0/22 (0%)	0	0/18 (0%)	0
Rash	1/22 (4.5%)	1	1/20 (5%)	1	1/22 (4.5%)	1	0/18 (0%)	0
Rash macular	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Heat rash	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1
Skin chapped	1/22 (4.5%)	1	0/20 (0%)	0	0/22 (0%)	0	0/18 (0%)	0
Vascular disorders
Peripheral coldness	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/18 (0%)	0
Peripheral vascular disorders	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.