Proof of concept study of RECCE®327 topical antibiotic therapy for infected burn wounds

Polyacrolein polyethylene glycol oligomer mixture (0.045 gram/gram) will be administered topically as a spray solution to saturate the wound over a 14 day treatment period. The first ten participants will be allocated to daily application; in practical terms this will mean at least five applications within the first seven days of treatment. The next twenty participants will be allocated to three times a week application. Dressing changes will be aligned with antibiotic application. During each outpatient clinic visit, the burn wound site will be assessed clinically and study assessments completed. Thereafter, as needed, irrigation and debridement of the wound will be performed in accordance with the standard Burns Unit procedures avoiding chlorhexidine and other cleansing agents with residual effect. Antibiotic will be administered by a dressing clinic nurse. The antibiotic will be sprayed onto the whole of the infected burn ulcer until the wound is visibly wet/saturated throughout. The wound will be then left open until visibly dried or for at least five minutes before applying a dressing. This will be to ensure adequate absorption of the topical antibiotic into the burn wound bed, to prevent immediate uptake into dressings and maximise the clinical efficacy of this antimicrobial preparation. The wound will then be covered using a standard foam dressing. Adherence to the intervention will be monitored with records of the number of dressings attended, the number of antibiotic administrations and the number of pumps delivered. All the procedures, including opening the wound, irrigation, debridement, the preparation and application of the topical antibiotic, and re-dressing, should take approximately 15 min to complete.