A revolutionary synthetic dermal template developed at the Royal Adelaide Hospital has completed a world-first multicentre clinical trial with positive results.
The NovoSorb® Biodegradable Temporizing Matrix (BTM) is an artificial foam-like material that is used to protect major wounds and burns and acts as a foundation for skin grafting.
The study was the first multicentre trial of the BTM in burns outside the Royal Adelaide Hospital, where the first 5 patient burn trial took place starting in 2014.
“This trial was an affirmation of the work that was done at the RAH Skin Engineering Laboratory and the Adult Burns Unit, led by Professor John Greenwood AM, in the development of the BTM,” said Associate Professor Marcus Wagstaff consultant plastic surgeon at the Royal Adelaide Hospital and one of the principal investigators on the study.
“We’d shown that it worked in our hands, but it was important that it was demonstrated to work in other teams’ hands as well.”
Thanks to a coordinated effort between Associate Professor Wagstaff and surgical teams at The Alfred Hospital, Melbourne, the Royal North Shore Hospital, Sydney, Concord Repatriation General Hospital, Sydney, and the Royal Brisbane and Women’s Hospital, the outcome was a successful trial of the BTM in thirty burn patients.
“What it means is BTM works. It’s safe and does what it claims to do. It integrates and can then support overlying skin once it’s integrated,” said Associate Professor Wagstaff.
On average 88.6 per cent of the BTM successfully integrated with the skin of the patients, and 81.9 per cent of subsequent overlying skin grafts survived.
“These results support the efficacy of BTM use in patients with significant burns”
About the BTM
The BTM was designed to help surgeons treat major burns and other traumatic wounds which destroy large portions of the surface of the skin (epidermis) and its deeper layers (dermis).
It temporarily closes the wound and prevents moisture loss and supports the integration of new blood vessels and tissue. This then provides a favourable structure upon which skin grafts can then be overlayed.
The results of the recent trial are a further step forward for the product, which is gaining increasing usage around the world thanks to a number of advantages.
“It is simple to apply and appears to be more sustainable in the presence of infection, and once integrated, it readily accepts skin graft through to healing,” said A/Prof Wagstaff.
“People around the world are using this paper to inform their practice and using BTM themselves as opposed to the existing technology.”
The BTM has also proven to be useful in myriad applications, beyond the purposes the developers initially imagined.
“Due to its reliability, surgeons are diversifying with it as a product and using it in ways that weren’t imagined during its first years of use” said Associate Professor Wagstaff.
One example is following reconstruction of the skin after hidradenitis suppurativa, an inflammatory and infective condition that causes small, painful lumps to form under the skin.
“After excision of the hidradenitis skin grafts are notoriously difficult to take, and different units across the world have chosen to use BTM to facilitate this with good results, which we hadn’t really anticipated,” said Associate Professor Wagstaff.
Next step: artificial skin
At the Skin Engineering Laboratory at the RAH, the vision and work of Professor Greenwood continues toward the ultimate goal of developing a complete, laboratory-grown, full thickness skin reconstruction. This would alleviate the reliance on cadaveric skin donation, which is in short supply around the world, as well as donor skin grafts from the patient.
“The first stage was to create a temporising stage or foundation and that’s what BTM is,” said Associate Professor Wagstaff.
Using a bioreactor donated from Skin Tissue Engineering, the team are currently refining the growth of the composite skin of the dermis and epidermis, making it more reliable and effective. Their aim is to start clinical trials within approximately 18 months.
“This wouldn’t have been possible without the BTM,” concluded Associate Professor Wagstaff.