A first-in-human clinical trial of a bioactive dressing designed to reduce scarring of skin burns
Superficial partial thickness thermal burn(s) between 3-20% Total Body Surface Area
The DeScar trial is made up of three stages, and will involve 25 volunteer participants with heat burn wounds covering 3-20% of their body surface. All of the burn dressings used will be 10cm x 10cm in size. For each participant, two burn areas will be selected for study treatment, with a different type of dressing used on each area for comparison. In all 3 study stages, dressings will be changed every 3 days for 21 days or until the wound has healed. After treatment, there will be a follow-up period of 6 months for all stages. The three study stages are: Stage 1: Comparing Standard of Care NHS dressing (called urgotul) and Gel-SOLO dressing (gel based dressing) in 2 participants. Stage 2: Comparing Standard of Care NHS dressing and Gel-PLUS dressing (gel based dressing with decorin added) in 2 participants. Stage 3: Participants randomised via an electronic database to receive either: • Standard of care NHS dressing and Gel-SOLO dressing; 7 participants • Standard of care NHS dressing and Gel-PLUS dressing; 7 participants • Gel-SOLO dressing and Gel-PLUS dressing; 7 participants
1. Male or female patients aged ≥16 years old 2. Superficial partial thickness thermal burns covering 3 - 20% of TBSA determined by clinical judgement
1. Deep/full thickness burns 2. Burn injury occurred more than 72 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. Co-morbidities which may interfere with the aim(s) of the trial. 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 trial (IMP/medical device), which may affect the results of this trial 12. A history of clinically significant hypersensitivity to any of the components of the trial dressings or procedural medication used in this trial 13. Known multiple allergic disorders 14. Not willing or able to comply with the trial visits and assessment schedule 15. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness or ability to follow trial procedures. 16. Any other reason that the clinician considers will interfere with the objectives of the trial 17. A woman who is pregnant or breastfeeding 18. A woman of child-bearing potential (WOCBP) who does not agree to use a highly effective method of birth control during heterosexual intercourse from screening until 30 days after last trial treatment. 19. A male who is not vasectomised and does not agree to use barrier contraception (condom plus spermicide) during heterosexual intercourse from screening until 30 days after last trial treatment.