A first in human subjects clinical trial of a bioactive dressing designed to reduce scarring of skin burns

Phase 1

• Conditions: Superficial partial thickness thermal burn(s) between 3-20% Total Body Surface Area; Skin and Connective Tissue Diseases; Second degree burn wounds

• Registration Number: ISRCTN15170461
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-25
• Last Update Posted: 12 February 2024
• Study Completion: 2026-02-09

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 25

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified