Skin Wound
Conditions
Keywords
Scar, Skin, Wound Healing, Tissue Engineering, Dermis, Epidermis
Brief summary
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
Detailed description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. 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
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: ≥1 years of age * Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap) * Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2 * 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) * 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 STSG based on the assessment of scar quality | 3 months post grafting | Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events. | through study completion, an average of 3 years | Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events. |
| Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality | 3 months and 1 year +/- 30 days post grafting | Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement |
| A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality | 3 months and 1 year +/- 30 days post grafting | Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,. |
| Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation | 28 +/- 3 days post grafting | Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area. |
| Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take. | 4-11 days post grafting | Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take |
| Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate. | 4-11 days and 19-23 days post grafting | Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation. |
| Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. | 1 +/- 30 days year post grafting | Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory") |
Countries
Italy, Netherlands, Switzerland
Contacts
STUDY_CHAIRClemens Sc, Prof.
University Children's Hospital, Zurich
Outcome results
None listed