None listed
Conditions
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.
Interventions
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 dre
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.
Sponsors
VARNZ Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed