Trial Outcomes & Findings for Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage (NCT NCT01096589)
NCT ID: NCT01096589
Last Updated: 2024-10-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
baseline and after 3 weeks of treatment
Results posted on
2024-10-02
Participant Flow
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.
Participant milestones
| Measure |
Arm 1 - 3M Oedema Reduction System
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
22
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
4
|
3
|
Reasons for withdrawal
| Measure |
Arm 1 - 3M Oedema Reduction System
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
|
Overall Study
Compliance with protocol
|
0
|
0
|
1
|
0
|
|
Overall Study
found treatment exhausting
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
Baseline characteristics by cohort
| Measure |
Arm 1 - 3M Oedema Reduction System
n=22 Participants
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
n=20 Participants
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
n=22 Participants
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
n=18 Participants
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
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Age, Continuous
|
59.73 years
STANDARD_DEVIATION 13.29 • n=5 Participants
|
61.85 years
STANDARD_DEVIATION 14.49 • n=7 Participants
|
62.27 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
56.22 years
STANDARD_DEVIATION 14.78 • n=4 Participants
|
60.16 years
STANDARD_DEVIATION 13.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
16 participants
n=4 Participants
|
70 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and after 3 weeks of treatmentPopulation: Patients must have completed the first week.
Outcome measures
| Measure |
Arm 1 - 3M Oedema Reduction System
n=18 Participants
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
n=20 Participants
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
n=22 Participants
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
n=16 Participants
Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
|---|---|---|---|---|
|
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
|
-14.56 % volume change measured in mL.
Standard Deviation 12.22
|
-7.09 % volume change measured in mL.
Standard Deviation 7.30
|
-10.24 % volume change measured in mL.
Standard Deviation 8.65
|
-9.84 % volume change measured in mL.
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: 3 weeksOutcome measures
| Measure |
Arm 1 - 3M Oedema Reduction System
n=22 Participants
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
n=20 Participants
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
n=22 Participants
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
n=18 Participants
Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
|---|---|---|---|---|
|
Assessment of Safety by Incidence of Adverse Events.
|
13 No. of treatment-emergent adverse events
|
11 No. of treatment-emergent adverse events
|
14 No. of treatment-emergent adverse events
|
10 No. of treatment-emergent adverse events
|
Adverse Events
Arm 1 - 3M Oedema Reduction System
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 2 - 3M Oedema Reduction System
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 3 - 3M Oedema Reduction System
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm 4 - Commercial Compression System 5 Apps/wk
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - 3M Oedema Reduction System
n=22 participants at risk
3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 2 - 3M Oedema Reduction System
n=20 participants at risk
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 3 - 3M Oedema Reduction System
n=22 participants at risk
3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
|
Arm 4 - Commercial Compression System 5 Apps/wk
n=18 participants at risk
Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
|
|---|---|---|---|---|
|
General disorders
Medical device discomfort
|
9.1%
2/22 • Number of events 2
|
15.0%
3/20 • Number of events 5
|
9.1%
2/22 • Number of events 4
|
16.7%
3/18 • Number of events 6
|
|
General disorders
Application site discomfort
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
18.2%
4/22 • Number of events 5
|
11.1%
2/18 • Number of events 3
|
|
General disorders
Application site irritation
|
0.00%
0/22
|
10.0%
2/20 • Number of events 2
|
0.00%
0/22
|
0.00%
0/18
|
|
General disorders
Application site reaction
|
4.5%
1/22 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Application site erythema
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Application site paraethesia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
General disorders
Application site swelling
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Discomfort
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fibrosis
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
General disorders
Generalised oedema
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
General disorders
oedema peripheral
|
0.00%
0/22
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
13.6%
3/22 • Number of events 4
|
5.0%
1/20 • Number of events 3
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • Number of events 1
|
10.0%
2/20 • Number of events 4
|
0.00%
0/22
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • Number of events 2
|
10.0%
2/20 • Number of events 4
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Gastrointestinal disorders
Food poisoning
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Folliculitis
|
4.5%
1/22 • Number of events 2
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/22
|
5.0%
1/20 • Number of events 2
|
0.00%
0/22
|
0.00%
0/18
|
|
Nervous system disorders
Neuralgia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Vascular disorders
Peripheral vascular disorders
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/22
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
General disorders
Application site vesicles
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Malaise
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/22
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Clellulitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/18
|
Additional Information
Prof. Christine Moffatt, Principal Investigator
Centre for Reasearch and Implementation of Clinical Practice (CRICP)
Phone: +44 20 73 51 14 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60