Feasibility of ultrasound-activated microbubble–assisted topical antibiotic delivery in infected partial-thickness burns: a randomised controlled trial.
Medical condition: Infected partial-thickness burn wounds (superficial to deep partial-thickness confluent wounds affecting <4% TBSA). Medical condition in lay language: Infections in small burn wounds — specifically partial-thickness burns that have become infected and require treatment during hospital admission. Therapeutic areas: Diseases [C] - Bacterial Infections and Mycoses [C01]
This is a single-centre, randomised controlled feasibility study with four parallel arms (1:1:1:1). Participants are inpatient adult burn patients with clinically infected partial-thickness burns managed without skin grafting. All groups receive standard of care, comprising systemic antibiotics as per local burns SOPs, wound cleaning, antiseptic dressing (Bactigras), and routine inpatient monitoring. All arms are followed during admission and routine outpatient care until wound healing. • Arm 1 Standard of Care (Primary Control, open label): Participants receive standard wound care and systemic antibiotics only. No study gel or ultrasound is applied. • Arm 2 Standard of Care + Ultrasound-activated microbubbles with gentamicin (Intervention) Participants receive topical gel containing ultrasound-responsive microbubbles (Luminity®) combined with gentamicin 80 mg (40 mg/mL formulation). Dose: 80 mg gentamicin per application (topical) Route: Topical application to wound surface Frequency: Once daily Duration: Up to 3 treatment sessions Ultrasound parameters: 1 MHz ultrasound applied for 30 seconds to 2 minutes per treatment site • Arm 3 Standard of Care + Ultrasound-activated microbubbles without gentamicin (Treatment Control 1) Participants receive topical gel containing ultrasound-responsive microbubbles (Luminity®) but without antibiotic. Route: Topical application to wound surface Frequency: Once daily Duration: Up to 3 treatment sessions Ultrasound parameters: 1 MHz ultrasound applied for 30 seconds to 2 minutes per treatment site • Arm 4 Standard of Care + Microbubbles with gentamicin without ultrasound activation (Treatment Control 2) Participants receive topical gel containing ultrasound-responsive microbubbles (Luminity®) combined with gentamicin 80 mg (40 mg/mL formulation) but without ultrasound activation. Dose: 80 mg gentamicin per application (topical) Route: Topical application to wound surface Treatment is delivered once daily for a maximum of three
1. Adults aged ≥18 years. 2. Admitted to the regional burn unit at Buckinghamshire Healthcare NHS Trust. 3. Clinically infected superficial or partial-thickness thermal burn wounds (superficial to deep partial-thickness) affecting ≤4% total body surface area (TBSA). 4. “Clinically infected” is defined by clinical signs observed by the treating team (e.g. erythema, pain, swelling, purulence) and symptoms reported by the patient. 5. Able to provide informed consent and with mental capacity to understand the study requirements. 6. Inpatients with burns being managed without surgical grafting. 7. Patients who have undergone surgical debridement (e.g. Versajet) but not grafting are eligible. 8. Willing and able to comply with study procedures and follow-up during hospital admission.
The participant may not enter the study if ANY of the following apply: Trial design–related: 1. Wounds involving >4% total body surface area (TBSA) 2. Full-thickness or chemical burns 3. Wounds requiring grafting as part of treatment 4. Participation in another clinical trial involving burn treatment or antibiotics Products: 1. Optilube: Known allergy or hypersensitivity to any component of Optilube 2. Luminity: Known allergy or hypersensitivity to any excipients in Luminity 3. Gentamicin: Known allergy or hypersensitivity to gentamicin or any of its excipients 4. Known contraindication to gentamicin use 5. Concomitant use of nephrotoxic or ototoxic medications 6. History of serious aminoglycoside toxicity 7. Pre-existing auditory or vestibular disease Ultrasound-related: 1. Presence of metallic implants within or near the treatment area (risk of heating) 2. Presence of other dermatoses in the treatment area (e.g. eczema, psoriasis) 3. Known or suspected pregnancy, or currently breastfeeding 4. Presence of methicillin-resistant Staphylococcus aureus (MRSA) infection 5. Myasthenia gravis 6. Current treatment with immune-modulating drugs (e.g. corticosteroids, anti-rejection therapy, chemotherapy)