The primary purpose of the prospective study is to evaluate the safety and performance of a novel, biodegradable dermal matrix (BTM) for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting. This is a multicentre trial with study sites in Australia and France. Patients will undergo assessment of the integration of BTM, the clinical outcome of the skin grafting procedure, wound contracture and scar quality at intervals up to 12 months after implantation of BTM.

The primary purpose of the prospective FDA Investigational Device Exemption (IDE) study is to evaluate the safety and performance of a novel, biodegradable dermal matrix (BTM) for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting. This is a multicentre trial with study sites in the USA. Patients will undergo assessment of the integration of BTM, the clinical outcome of the skin grafting procedure, wound closure, joint contracture, scar severity, skin itch at intervals up to 12 months after implantation of BTM. An assessment of surgeon ease of use of BTM will also be recorded. This FDA-approved Feasibility Trial will guide the study design for a subsequent Pivotal Trial.

BTM can be implanted into deep and complex wounds that cannot be closed by simple suturing. One example of such wounds is those created when free flaps are surgically transferred from one area of the body to another. These are blocks of tissue containing skin, fat, fascia and/or bone for use in reconstruction of a similarly complex defect created following excision of a cancer, benign mass or trauma. Common sites for flap donation are the thigh, forearm and lower leg.

The initial pilot study assessed the use of BTM for free flap donor site reconstruction in a group of 10 patients. This first series provided favourable clinical data, with BTM integration occurring in all patients (Wagstaff et al., 2015. Some of the clinical findings prompted minor changes to the BTM seal and bond.

Based on these results, approval was sought and granted from the Australian Therapeutic Goods Administration (TGA) for appointed surgeons at the Royal Adelaide Hospital to use BTM as a treatment option for free flap donor site reconstruction outside of a trial setting, in accordance with the Authorised Prescribers Scheme. A second cohort of 10 patients was subsequently treated and the clinical outcomes at up to 12 months reported (Wagstaff et al, 2015).

This is a five-patient prospective cohort trial of significant full-thickness burn injuries covering 20–50% total body surface area. Following initial debridement and stabilisation of the patient, the optimised BTM was applied.  The study aims included assessing the ability of Novosorb® BTM to integrate into extensive wounds following initial tissue removal after the burn injury, temporising the wounds until delamination, and to provide a neodermis to support application of a split-thickness skin graft.  Scar assessment at 12 months post-injury was also performed.  In all patients, the BTM: was easy to cut, apply and fix; easy to monitor; integrated completely into the wounds; delaminated in a single piece with a single action; allowed successful complete skin graft take on all integrated BTM.  The scar results at 12 months were very good, considering the size and depth of the burn injuries. The results of this study have since been published by Greenwood et al, 2018.

Full text available with this link

A randomised controlled trial of negative pressure wound therapy for 20 pressure ulcers in 18 patients was performed, 10 ulcers treated with NovoSorb, and 10 ulcers treated with the GranuFoam (Kinetic Concepts, Inc.). Dressings were changed every 2–3 days with results collected over an eight-week period.

No adverse reaction to NovoSorb was noted. Novosorb was easier to remove because of low marginal integration of granulation tissue into NovoSorb in the short term. Any retained fragments were removed by wound irrigation. GranuFoam was more difficult to remove, caused bleeding, and fragmented more on removal, with retained fragments forming a focus for starting infection. NovoSorb was as effective as the GranuFoam in reducing wound area over time. These results of this study have since been published (Wagstaff et al., 2014).