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Trial registered on ANZCTR


Registration number
ACTRN12613001332718
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
4/12/2013
Date last updated
4/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Treatment of Acute and Chronic Wounds using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate
Scientific title
The effect of autologous stromal vascular fraction (SVF) on healing time of acute and chronic wounds
Secondary ID [1] 283047 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic venous ulcer 289882 0
Condition category
Condition code
Skin 290246 290246 0 0
Other skin conditions
Cardiovascular 290287 290287 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective randomized controlled study of patients from Royal Adelaide Hospital with venous ulcers on their leg. Autologous lipoaspirate will be collected from patients in groups 1 and 2 using syringe aspiration from a healthy donor site. Group 1 will have their lipoaspirate sample centrifuged in the operating theatre and subsequently injected into the wound. Group 2 will have their lipoaspirate sample processed in a sterile laboratory to isolate the SVF and subsequently injected into the wound. Group 3 will have no autologous lipoaspirate harvest or injection. The primary outcome measured will be time to complete wound closure.


Aspiration and injection procedure:
The procedure will be performed under local anaesthetic and sedation in an operating theatre. This will involve intravenous sedation being administered by an Anesthetist. Following this local anaesthetic will be administered by the operating surgeon.

Prophylactic antibiotics will be given at the time of surgery.
First the ulcer will be gently debrided to remove any debris.

Following standard tumescent infiltration, autologous lipoaspirate will be harvested from the thigh or abdominal region using syringe aspiration with a 2mm diameter cannula and a 10ml syringe. A total volume of 20ml of adipose will be obtained from each patient.

Group 1. The lipoaspirate sample will be centrifuged in theatre at the bedside and immediately injected in theatre. The patient will then be woken from their anaesthetic.

Group 2. The lipoaspirate sample will be immediately transferred to a Class 350 laboratory (SA Pathology-Therapeutic Products Facility, Haematology). The patient will then be woken from their anaesthetic. The SVF once processed will be injected immediately after isolation under local anaesthetic on the same day (60-90 minutes).

Injection technique
For groups 1 and 2, the sample for injection will be transferred to a 1ml syringe. An 18-gauge needle will be used for injection. The sample will be carefully deposited at the dermal-epidermal junction at the edges of the ulcer and also directly subjacent to the wound bed.
Multiple radiating passages will be made through the same insertion site to disperse the sample in different directions. Injection will only be performed on axial withdrawal of the needle. The volume of tissue grafted beneath the wound will be a function of the size of open wound and scar requiring treatment. As a rule, 1ml of sample will be injected for each 2.5cm2 area of open wound surface. Care will be taken to avoid overgrafting.
All wounds will be dressed with gelonet, gauze and multilayer compression stockings. Patients will be discharged the following day.
Intervention code [1] 287765 0
Treatment: Other
Comparator / control treatment
Group 3 will have no aspiration or injection
Control group
Active

Outcomes
Primary outcome [1] 290266 0
All patients will be reviewed at weekly intervals to assess clinical progress in the Plastics outpatients clinic. A Registered Nurse who is blinded to the treatment group will perform assessment.
Clinical photography
Digital measurement of ulcer size using Visitrak (Smith & Nephew)
Clinical assessment of any complications such as infection.

The primary outcome measure will be ulcer healing. Ulcer healing was defined as complete re-epithelialisation of the leg.
Timepoint [1] 290266 0
Assessed weekly until the ulcer has healed
Secondary outcome [1] 304223 0
infection - clinical assessment, microbiology, blood tests
Timepoint [1] 304223 0
Assessed weekly until the ulcer has healed

Eligibility
Key inclusion criteria
- Male or female, aged >18 years
- Venous ulceration for longer than 4 weeks between the knee and malleoli
- Ulcer size <10cm2
- Ankle brachial pressure index of 0.85 or greater
- superficial or deep venous reflux on duplex scanning.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- duplex scanning not possible
- multilayer compression therapy not practical
- those who are unable or unwilling to give informed consent
- those with deep venous occlusion
- those unfit for local anaesthetic and sedation
- those with malignant ulceration.
- infection, cellulitis, or osteomyelitis in the affected leg diagnosed by MRI and microbiologic culture results

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)
Consecutive enrollment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation method – randomization will take place immediately following recruitment. Computer generated random numbers will be sealed in sequentially numbered envelopes. Group allocation will be independent of time, place, and person delivering the treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were based on the requirement that effects be detected at the 0.05 alpha-level with 80% statistical power. Based on available evidence, it was assumed that the hazard rate in the optimum treatment group would be 0.4 and that survival time would follow an exponential distribution. A sample size of 19 patients per treatment group would be required to detect a hazard ratio of 2.5 across treatment arms under these assumptions. If the clinically meaningful effect was determined to be a hazard ratio of 2.0 across treatment arms, then a sample of 30 patients per group would be required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1449 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287811 0
Hospital
Name [1] 287811 0
Royal Adelaide Hospital
Country [1] 287811 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Level 5, North Wing Link
North Terrace
5000
Adelaide
SA
Country
Australia
Secondary sponsor category [1] 286540 0
None
Name [1] 286540 0
Address [1] 286540 0
Country [1] 286540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289761 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 289761 0
North Terrace
5000
Adelaide
SA
Ethics committee country [1] 289761 0
Australia
Date submitted for ethics approval [1] 289761 0
25/10/2013
Approval date [1] 289761 0
03/12/2013
Ethics approval number [1] 289761 0
HREC/13/RAH/444

Summary
Brief summary
Clinical Treatment of Venous Ulcers using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate

INTRODUCTION
Stromal vascular fraction (SVF) harvested from lipoaspirate consists of a heterogenous mixture of cell types including adipose-derived stem cells (ASC), fibroblasts and endothelial cells. There is evidence to suggest that the cells contained in SVF have angiogenic and regenerative properties that may be effective in treating venous ulcers.

OBJECTIVE
The goal of this study is to determine the effectiveness of autologous stromal vascular fraction (SVF) from lipoaspirate for the treatment of venous ulcers.

METHODS
Prospective randomized controlled study of patients from Royal Adelaide Hospital with venous ulcers on their leg. Autologous lipoaspirate will be collected from all patients using syringe aspiration from a healthy donor site. Group 1 will have their lipoaspirate sample centrifuged in the operating theatre and subsequently injected into the wound. Group 2 will have their lipoaspirate sample processed in a sterile laboratory to isolate the SVF and subsequently injected into the wound. Group 3 will have no injection. The primary outcome measured will be time to complete wound closure.

CONCLUSION
The results of this study will be statistically analysed and summarised, will be presented at a plastic surgery conference, and will be submitted for publication in a peer-reviewed journal.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 42282 0
Dr Raakhi Mistry
Address 42282 0
Royal Adelaide Hospital
Level 5, North Wing Link
North Terrace
Adelaide 5000
SA
Country 42282 0
Australia
Phone 42282 0
+61420970408
Fax 42282 0
Email 42282 0
[email protected]
Contact person for public queries
Name 42283 0
Raakhi Mistry
Address 42283 0
Royal Adelaide Hospital
Level 5, North Wing Link
North Terrace
Adelaide 5000
SA
Country 42283 0
Australia
Phone 42283 0
+61420970408
Fax 42283 0
Email 42283 0
[email protected]
Contact person for scientific queries
Name 42284 0
Raakhi Mistry
Address 42284 0
Royal Adelaide Hospital
Level 5, North Wing Link
North Terrace
Adelaide 5000
SA
Country 42284 0
Australia
Phone 42284 0
+61420970408
Fax 42284 0
Email 42284 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.