Burns
Conditions
Keywords
Burns, Scar, Skin, Wound healing, Tissue Engineering, Dermis, Epidermis, Thermal Injuries
Brief summary
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.
Detailed description
This multicentre phase IIb clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.
Interventions
Sponsors
CUTISS AG
Wyss Zurich
Julius Clinical
Sintesi Research Srl
University Hospital, Zürich
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: ≥12 years of age * Deep partial thickness and/or full thickness burns requiring surgical wound coverage * Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion. * Signed Informed consent
Exclusion criteria
* Patients tested positive for HBV, HCV, syphilis or HIV * Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing) * Severe drug and alcohol abuse * Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion * Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen * Previous enrolment of the patient into the current phase II study * Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study * Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) * Pregnant or breast feeding females * Intention to become pregnant during the clinical course of the study (12 months) * Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands) * Enrolment of the Investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface | 4 weeks post grafting | Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection | 4-11 days post grafting and 21 +/-2 days post grafting | Evaluation of clinical signs of infection at experimental area and control area |
| Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection | 4-11 days post grafting and 21 +/-2 days post grafting | Evaluation of microbiologic signs of infection at experimental area and control area |
| Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R) | 1 year +/-30 days post grafting | Assessment of elasticity of experimental area and control area using Cutometer(R) |
| Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of General scar quality using POSAS assessment tool | 1 year +/-30 days post grafting | Assessment of general scar Quality of experimental area and control area using POSAS assessment tool |
Countries
Italy, Netherlands, Switzerland
Contacts
STUDY_CHAIRClemens Schiestl, Prof.
University Children's Hospital, Zurich
Outcome results
None listed