Superficial partial thickness thermal burn(s) between 3-20% Total Body Surface Area Skin and Connective Tissue Diseases Second degree burn wounds
Conditions
Interventions
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 i
7 participants
• Standard of care NHS dressing and Gel-PLUS dressing
7 participants
• Gel-SOLO dressing and Gel-PLUS dressing
7 participants
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =16 years old 2. Superficial partial thickness thermal burns covering 3 - 20% of TBSA determined by clinical judgement
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed by: 1. Occurrence of Gel Limiting Toxicity (GLT) defined as the occurrence of any of the following during the 6-day assessment window that is determined as related to Gel-SOLO or Gel-PLUS 2. Microbial colonisation as confirmed by numerating colony-forming units from microbiology swab samples at each dressing change Tolerability will be assessed by: 1. A pain Visual Analogue Scale (VAS) evaluated by patients before the dressing change visits and within 15 minutes of the new dressing being applied | — |
Secondary
| Measure | Time frame |
|---|---|
| For secondary objective #1 – to assess wound healing progress: 1. Time to 95% wound healing subjectively assessed using: 1.1. Independent, real time visual clinical assessment of percentage wound healing 1.2. 2D photograph assessment of percentage wound healing – assessed by three independent, blinded assessors. 2. Rate of wound healing will be measured objectively at three areas per wound half (the periphery, mid-zone and centre of wound), using measurement of transepidermal water loss (TEWL) by Tewameter For secondary objective #2 – to assess rate and severity of pathological scarring of the wounds post-healing: 1. Scar size measured by calculating scar surface area 2. Scar quality using a panel of objective scar measurement devices at the periphery, mid-zone and centre from time of complete wound healing to 6 months (DermaScan high frequency ultrasound for scar thickness) 3. Subjective measures of scar quality from time of complete wound healing to 6 months using the Brisbane Bars Scar Impact Profile (BBSIP) Score. | — |
Countries
England, United Kingdom
Outcome results
None listed