Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000717550
Ethics application status
Approved
Date submitted
1/06/2015
Date registered
10/07/2015
Date last updated
16/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the safety and tolerability of RepaiRx in donor site healing
Scientific title
Can deer antler extract improve tissue healing of a skin graft donor site?
Secondary ID [1] 286429 0
Nil
Universal Trial Number (UTN)
UTN1111-1166-5084
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing 294597 0
Condition category
Condition code
Skin 294899 294899 0 0
Other skin conditions
Injuries and Accidents 295536 295536 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RepaiRx (10ml or 5ml, depending on the donor site size) will be applied as a gel. It is spread directly onto the surface of the wound using a sterile flat-bladed instrument by the burns surgeon in the operating theatre. RepaiRx is applied as a thick gel to one of the donor sites as per the randomisation code and covered with Mepitel film. It is expected that this will remain in place until removed for Day 4 assessments; if needed additional external bandaging can be applied to hold the study dressings in place. After that the site normal management of donor site wounds will be applied.

RepaiRx is a biological product reproducibly produced via controlled extraction of New Zealand red deer velvet antler using the proprietary process developed by VARNZ.It is a complex biological mixture of peptides/polypeptides (these predominantly having molecular weights less than 10 kDa), 9.1% W/W amino acids, mineral salts and other water-soluble components of deer velvet tissue. The exact nature of the active ingredients is thus not well defined.
Intervention code [1] 291506 0
Treatment: Drugs
Intervention code [2] 292060 0
Treatment: Other
Comparator / control treatment
The same volume of Control (carrier medium minus RepaiRx) will be applied to the remaining donor site as per the randomisation directive. The carrier medium is a gel containing Poloxamer 407, which is marketed by BASF under the trade name Kolliphor P 407 (formerly Lutrol F 127) (CAS No. 9003-11-6).
Control group
Placebo

Outcomes
Primary outcome [1] 294654 0
The primary objective is to assess the safety and tolerability of RepaiRx in terms of the nature, relatedness, severity and incidence of adverse events reported in the course of the study. This is the first in man study of RepaiRx so the possible adverse events are not known but may include allergic reactions and wound infections.
Timepoint [1] 294654 0
From Screening and at each site visit to Month 6 (i.e. Days 0, 4, 5, 7, 10, 14, 28 and Months 3 and 6). Participants will be asked if they have experienced any adverse effects at each study visit. The patients will have physical exams and the wounds will be examined for signs of infection.
Secondary outcome [1] 313805 0
Donor site evidence of infection, as assessed by a masked sub-investigator, requiring antibiotic treatment
Timepoint [1] 313805 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6
Secondary outcome [2] 313807 0
Trans-Epidermal Water Loss (TEWL) measurements using a specialised TEWL machine (DermaLab Series, SkinLab Combo).
Timepoint [2] 313807 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6
Secondary outcome [3] 313808 0
Donor site appearance to be estimated visually (1) in situ by a masked sub-investigator and (2) by a masked independent assessor's sight of photographs: Healing assessments - VAS of wound healing
Timepoint [3] 313808 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6
Secondary outcome [4] 313809 0
Scar assessment using POSAS [Patient and Observer Scar Assessment Scale" for POSAS] (i.e. by participants and by a masked sub-investigator)
Timepoint [4] 313809 0
Day 28, at 3 and 6 months
Secondary outcome [5] 315227 0
Donor site appearance to be estimated visually (1) in situ by a masked sub-investigator and (2) by a masked independent assessor's sight of photographs - VAS of colour match and pigment match
Timepoint [5] 315227 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6
Secondary outcome [6] 315228 0
Donor site appearance to be estimated visually (1) in situ by a masked sub-investigator and (2) by a masked independent assessor's sight of photographs: Opinion of which site is better healed
Timepoint [6] 315228 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6
Secondary outcome [7] 315229 0
Donor site appearance to be estimated visually by a masked sub-investigator and by masked independent assessor using photographs: Healing assessments - level of healing and blistering by choosing one of 4 options listed for each of the two donor sites
Timepoint [7] 315229 0
Days 4, 5, 7, 10, 14 and 28, and at Months 3 and 6

Eligibility
Key inclusion criteria
Males and females aged at least 18 years requiring split thickness skin grafts for reasons of burn therapy, trauma or scar revision. The area requiring skin grafting is to be greater than or equal to 1% and no more than 20% of the total body surface area.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing infection or condition or taking medication that may interfere with wound healing; airway burn; renal failure requiring dialysis; participation in other clinical trial/s; known allergy to deer products, poloxamer gel or mepitel film;history of skin disorders

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)
After obtaining consent and confirming eligibility, the participant will be enrolled in the study. Randomisation will occur prior to administration of Investigational Product (IP) on Day 0. As two donor sites will be demarcated on each participant, the participant acts as their own control. Randomisation of the IP application to the donor sites (A and B) will be generated by the study statistician who will provide an individual randomisation envelope for each participant randomisation number. The randomisation envelope will be opened by the pharmacy delegate preparing the IPs just prior to surgery. The surgeon will be unmasked when applying the IPs and should usually be the clinician to manage any safety issues that may emerge. The Sub-Investigators will remain masked and will not have access to randomisation information; they will conduct the study assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
As two donor sites will be demarcated on each participant, the participant will have RepaiRx applied to one site and control to the other site. Therefore each participant acts as their own control.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Standard descriptive statistics including means, standard deviations, ranges, frequencies and percentages will be used to summarise participant demographic and presentation data including age, gender, ethnicity, vital signs, physical examination, biochemistry, haematology, urine dipstick, aetiology, area and location of treatment site location and area of donor site, presence of infection in donor site and concomitant medication.
All serious and non-serious adverse events will be listed and tabulated separately for the randomised treatments when appropriate, according to preferred terms, relatedness and severity classifications.
Standard descriptive statistics will be used to summarise the healing rate measures by randomised treatment. This will include means, medians, standard deviation and ranges for continuous measures and frequencies and percentages for categorical measures.

Randomised treatments will be compared using paired t-tests at the different assessment times and summaries of mean differences and 95% confidence intervals presented. If data are not adequately normal then comparisons will be made using non-parametric Wilcoxon signed rank tests. Categorical outcomes will be compared using McNemar’s chi-square tests. A two-tailed p-value <0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This study was terminated by the Sponsor, taking into account both the pain experienced by the first participant in undergoing wound healing assessment using the TEWL machine (despite pain management), and the low probability of recruiting around 20 participants in the next twelve months even were this assessment removed from the protocol.
Date of first participant enrolment
Anticipated
20/07/2015
Actual
23/06/2016
Date of last participant enrolment
Anticipated
15/09/2017
Actual
23/06/2016
Date of last data collection
Anticipated
20/12/2017
Actual
1/07/2016
Sample size
Target
20
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 6776 0
New Zealand
State/province [1] 6776 0
Auckland

Funding & Sponsors
Funding source category [1] 290999 0
Commercial sector/Industry
Name [1] 290999 0
VARNZ Ltd
Country [1] 290999 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
VARNZ Ltd
Address
c/- Deer Industry New Zealand
P.O Box 10-702
Wellington 6143
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289677 0
None
Name [1] 289677 0
Address [1] 289677 0
Country [1] 289677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292585 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 292585 0
Freyburg Building, 20 Aitken Street, PO Box 5013
Wellington 6011
Ethics committee country [1] 292585 0
New Zealand
Date submitted for ethics approval [1] 292585 0
Approval date [1] 292585 0
03/10/2012
Ethics approval number [1] 292585 0
NTX/12/05/039

Summary
Brief summary
This is a prospective, randomised, comparative, controlled pilot study of RepaiRx and Control. It will evaluate the safety, tolerability and effects on wounds, with each participant acting as their own control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56102 0
Mr Amber Moazzam
Address 56102 0
Consultant Plastic Surgeon
National Burn Centre
Middlemore Hospital
100 Hospital Road,
Otahuhu,
Auckland 2025
Country 56102 0
New Zealand
Phone 56102 0
+64 9 276 0044, Ext 7825
Fax 56102 0
Email 56102 0
Amber.Moazzam@middlemore.co.nz
Contact person for public queries
Name 56103 0
Mrs Catharine Sayer
Address 56103 0
c/o Deer Industry New Zealand
PO Box 10702
Wellington 6143
Country 56103 0
New Zealand
Phone 56103 0
+64 4 471 6116
Fax 56103 0
+64 4 472 5549
Email 56103 0
catharine.sayer@deernz.org
Contact person for scientific queries
Name 56104 0
Mrs Catharine Sayer
Address 56104 0
c/o Deer Industry New Zealand
PO Box 10702
Wellington 6143
Country 56104 0
New Zealand
Phone 56104 0
+64 4 471 6116
Fax 56104 0
+64 4 472 5549
Email 56104 0
catharine.sayer@deernz.org

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
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Documents added automatically
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