None listed
Conditions
Brief summary
In this pilot study, NexoBrid will be administered and its effectiveness will be assessed compared to the current surgical standard of care (SOC). This study will recruit 10 patients with upper limb burns treated with NexoBrid compared to 10 patients with upper limb burns receiving the SOC. It is hypothesised that the use of NexoBrid on acute thermal upper limb burns will reduce the patient length of stay in hospital.
Interventions
NexoBrid is a bromelain-based enzymatic debriding agent that is well established in many European burn centres. It is a lyophilised, partially purified, proteolytic protein mixture with increased specific enzyme activity derived from Bromelain raw material extracted from pineapple stems.
In the pilot study, NexoBrid will be administered to mid- to deep dermal and full thickness burns of the upper limb.
Nexobrid will be administered topically in a single session by a specialist Burns Surgeon for
NexoBrid is a bromelain-based enzymatic debriding agent that is well established in many European burn centres. It is a lyophilised, partially purified, proteolytic protein mixture with increased specific enzyme activity derived from Bromelain raw material extracted from pineapple stems. In the pilot study, NexoBrid will be administered to mid- to deep dermal and full thickness burns of the upper limb. Nexobrid will be administered topically in a single session by a specialist Burns Surgeon for a total of 4 hours with an occlusive dressing. Eligible patients will be consecutively allocated into either the NexoBrid or SOC group.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age 18 years or older - Patient consent/ willingness to participate and comply with study requirements - Thermal burn (flame, scald, contact) - TBSA less than 10% - Burn assessed to require surgical debridement - Burn depth: mid- to deep dermal and full thickness - Anatomical location of the burn isolated to the upper limb
Exclusion criteria
- Age less than 18 years - Patient decline to consent or unwillingness to participate and comply with study requirements - Chemical, crush or electrical burns or a penetrating burn wound where foreign materials or vital structures are or could become exposed during treatment - TBSA greater than 10% - NexoBrid contraindications based on manufacturer guidelines: - History of and/or known hypersensitivity/allergy to any of the following: pineapples, bromelain, papaya, papain - Smoke inhalation - Pregnant and/or breastfeeding/nursing - Compartment syndrome present - Coagulopathies, recent anticoagulant or antiplatelet medication - Pretreatment with betadine (astringent) or silver sulfadiazine (flamazine) (interference from silver)
Outcome results
None listed