Trial registered on ANZCTR


Trial ID
ACTRN12611000815965
Ethics application status
Approved
Date submitted
29/06/2011
Date registered
3/08/2011
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a biodegradable polyurethane foam in comparison with Granufoam (black, non-biodegradable foam) with Vacuum-Assisted Closure in the management of decubitus ulcers (pressure sores)
Scientific title
Safety and efficacy of vacuum assisted closure with a biodegradable polyurethane foam versus Granufoam in pressure sore sufferers.
Secondary ID [1] 262527 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure sores (decubitus ulceration) 268196 0
Condition category
Condition code
Skin 268323 268323 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New biodegradable polyurethane foam under topical negative pressure in standard treatment regimen (foams changed every 2-3 days) for 8 weeks.
Intervention code [1] 266873 0
Treatment: Devices
Comparator / control treatment
Commercially-available non-biodegradable polyurethane foam under topical negative pressure in standard treatment regimen (foams changed every 2-3 days) for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 269094 0
Ability to transmit topical negative pressure to the wound bed (assessed by odour, reduction of oedema, development of vascular granulations, cleanliness, wound area) with assessment by an independent specialist woundcare nurse, photographic analysis and wound area measurement.
Timepoint [1] 269094 0
Every 2-3 days for 8 weeks.
Secondary outcome [1] 276920 0
Safety (assessed by absence of local or systemic effects attributable to the new material). This can only be assessed by direct comparison with the control material, both within the study and against historical experience.
Timepoint [1] 276920 0
Every 2-3 days for 8 weeks.

Eligibility
Key inclusion criteria
Ischial or sacral pressure sore; >18 years old; suitable for topical negative pressure after wound debridement; able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy; inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment in community and hospital wound clinics after consultation with wound specialist and open discussion of the trial objectives and course. Allocation to foam type by random numbers generated in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Actual
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267345 0
Commercial sector/Industry
Name [1] 267345 0
NovoWound Pty Ltd
Address [1] 267345 0
Unit 2, 320 Lorimer Street, Port Melbourne 3207, Victoria
Country [1] 267345 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NovoWound Pty Ltd
Address
Unit 2, 320 Lorimer Street, Port Melbourne 3207, Victoria
Country
Australia
Secondary sponsor category [1] 266411 0
Hospital
Name [1] 266411 0
Royal Adelaide Hospital
Address [1] 266411 0
North Terrace, Adelaide 5000, South Australia
Country [1] 266411 0
Australia
Other collaborator category [1] 252084 0
Other Collaborative groups
Name [1] 252084 0
Royal District Nursing Service
Address [1] 252084 0
1, Richmond Road, Keswick 5035, South Australia
Country [1] 252084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269323 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 269323 0
Level 3, Hanson Institute (IMVS Building)
Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Ethics committee country [1] 269323 0
Australia
Date submitted for ethics approval [1] 269323 0
16/06/2011
Approval date [1] 269323 0
23/06/2011
Ethics approval number [1] 269323 0
110612

Summary
Brief summary
Comparison of new biodegradable foam against commercially available non-biodegradable foam under topical negative pressure dressings for safety and efficacy in transmitting the vacuum to the wound bed.
Trial website
Trial related presentations / publications
- Li A, Dearman BL, Crompton KE, Moore TG, Greenwood JE. Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. Journal of Burn Care and Research 2009;30(4):717-728.
- Greenwood JE, Li A, Dearman BL, Moore TG. Evaluation of NovoSorb novel biodegradable polymer for the generation of a dermal matrix. Part 1: In-vitro studies. Wound Practice and Research 2010;18(1):14-22.
- Greenwood JE, Li A, Dearman BL, Moore TG. Evaluation of NovoSorb novel biodegradable polymer for the generation of a dermal matrix. Part 2: In-vivo studies. Wound Practice and Research 2010;18(1):24-34.
- Greenwood JE. Biodegradable polyurethane as a dermal matrix. Journal of Burn Care and Research 2011; 32(2) (supplement):S58.
- Greenwood JE, Dearman BL. Split-skin graft application over an integrating, biodegradable temporising polymer matrix: Immediate and delayed. Journal of Burn Care and Research (accepted).
- Greenwood JE, Dearman BL. Comparison of a sealed, NovoSorb biodegradable temporising matrix (BTM) against Integra: a prospective, porcine study. Journal of Burn Care and Research (accepted).
Public notes

Contacts
Principal investigator
Name 32810 0
A/Prof John E Greenwood
Address 32810 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000 South Australia
Country 32810 0
Australia
Phone 32810 0
+61 8 8222 2233
Fax 32810 0
+61 8 8222 5676
Email 32810 0
john.greenwood@health.sa.gov.au
Contact person for public queries
Name 16057 0
A/Prof John E Greenwood
Address 16057 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 16057 0
Australia
Phone 16057 0
+61 8 8222 2233
Fax 16057 0
+61 8 8222 5676
Email 16057 0
john.greenwood@health.sa.gov.au
Contact person for scientific queries
Name 6985 0
A/Prof John E Greenwood
Address 6985 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 6985 0
Australia
Phone 6985 0
+61 8 8222 2233
Fax 6985 0
+61 8 8222 2233
Email 6985 0
john.greenwood@health.sa.gov.au