An open, first-in-human, blind-evaluated, single-centre, randomised, controlled, clinical Investigation to evaluate the safety and performance of GELLAN/Acetic Acid dressing in the treatment of burn wounds
Burn wounds
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. Participants should be entered into the study after the results of the screening process are available and this should be less than 48 hours before planned treatment start. For patients who appear to meet the criteria for participation in the study, the Investigator will provide the potential participant with the current approved Participant Information Sheet to allow them to make an informed decision regarding their participation. If informed consent is given, the Investigator will conduct a full screening evaluation to ensure that the patient satisfies all inclusion and exclusion criteria. The investigator will select a superficial partial thickness burn of between 2-25% of the participant’s total body surface area (TBSA) that can be divided into two zones measuring at least 10 x 10 cm each with a 2 cm gap in between. If this is not possible, two separate but comparable contralateral 10 x 10 cm burn zones can be selected. Each zone of the participant’s burn area will then be randomised to receive one of the two dressings. This information will be recorded in the participant’s medical notes and on the registration/randomisation case report form (CRF). The remaining areas of the wound(s) not covered by the experimental dressing (including the 2 cm gap between the two test dressings) will be covered with the Standard of Care dressing so that no part of the wound is left exposed during the healing process. The dressing will be applied by the study nurses on the ward or in an outpatient clinic depending on whether the participant has been discharged. Visit Schedule Visit 1: Baseline/Start of treatment (≤48 hours post burn injury [Day 0]) Visit 2 (3 days after Visit 1 [+/- 2 days]) Visits 3a, 3b, 3c, 3d, 3e (every 3 days (+/- 2 days) until full wound closure or Day 21 post b
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
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. Examp