Burn wounds Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients will be identified at the Queen Elizabeth Hospital Birmingham (QEHB). Potentially eligible participants with a burn of 2-25% TBSA will be approached by a member of the site burns team. Partic
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/09/2025: 1. =16 years of age. 2. Patients with thermal burns covering 2–25% of TBSA, including at least 2% confluent superficial partial thickness burns for randomisation (with a minimum surface area requirement for treatment zones – 2x 10cm2). If this is not possible, two separate but comparable contralateral 10cmx10cm burn zones can be selected. 3. Male and female participants of childbearing potential willing to use highly effective contraception (See Appendix 2). 4. Participant willing and able to comply with scheduled visits, treatment plan and other study procedures. 5. Written informed consent for the study. Previous inclusion criteria: 1. =16 years of age 2. Superficial partial thickness thermal burns covering 2-25% of TBSA determined by clinical assessment by a senior member of the team caring for the individuals 3. Male and female participants of childbearing potential willing to use highly effective contraception 4. Participants willing and able to comply with scheduled visits, treatment plan and other study procedures 5. Written informed consent for the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/09/2025: 1. Burn injury occurred more than 72 hours before planned treatment start 2. Chemical burns, electrical burns or cold burns 3. Burns of the head, neck, hands, feet or genitalia 4. Presence of obvious clinical infection in the wound (clinical judgement) 5. Poly-trauma with Injury Severity Score (ISS) > 25 6. Mechanically ventilated patients 7. Co-morbidities which may interfere with the aim(s) of the study. Examples include skin conditions such as pathological fibrosis, e.g. scleroderma; pathological thinning, e.g. epidermolysis, bullosa, and collagen disorders 8. Patients on immunosuppressant therapy 9. Chronic steroid use, history of skin malignancy or chronic papulosquamous disease (e.g. eczema, pemphigus), and history of Stevens-Johnson syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) disease 10. Participation in another interventional study (IMP/medical device), which may affect the results of this study 11. A history of clinically significant hypersensitivity to any of the components of the study dressings or procedural medication used in this study 12. Known multiple allergic disorders 13. Not willing or able to comply with the study visits and assessment schedule 14. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness or ability to follow study procedures. 15. Any other reason that the clinician considers will interfere with the objectives of the study 16. A woman who is pregnant or breastfeeding Previous exclusion criteria: 1. Deep/full thickness burns 2. Burn injury occurred more than 48 hours before planned treatment start 3. Chemical burns, electrical burns or cold burns 4. Burns of the head, neck, hands, feet or genitalia 5. Presence of obvious clinical infection in the wound (clinical judgement) 6. Poly-trauma with Injury Severity Score (ISS) > 25 7. Mechanically ventilated patients 8. Comorbidities which may interfere with the aim(s) of the study. Examples include skin conditions such as pathological fibrosis, e.g. scleroderma; pathological thinning, e.g. epidermolysis, bullosa, and collagen disorders 9. Patients on immunosuppressant therapy 10. Chronic steroid use, history of skin malignancy or chronic papulosquamous disease (e.g. eczema, pemphigus), and history of Stevens-Johnson syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) disease 11. Participation in another interventional study (IMP/medical device), which may affect the results of this study 12. A history of clinically significant hypersensitivity to any of the components of the study dressings or procedural medication used in this study 13. Known multiple allergic disorders 14. Not willing or able to comply with the study visits and assessment schedule 15. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness or ability to follow study procedures. 16. Any other reason that the clinician considers will interfere with the objectives of the study 17. A woman who is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and performance of GellanAA dressing, compared to Urgotul silver (Standard of Care) dressing measured whereby the safety will be assessed by the occurrence of any hypersensitivity or gel-limiting toxicity and the microbial colonisation at each wound change. Performance will be measured using a pain Visual Analogue Scale (VAS) at each wound change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early wound healing measured using photography of wound area (at all visits), microbial swabs at baseline (Visit 1), Visit 2, and Visits 3a-3e 2. Scarring at 3 months after injury assessed by measuring the scar surface area at Visits 4, 5 & 6 and performing a Dermascan at visits 5 & 6 | — |
Countries
United Kingdom
Outcome results
None listed