acute wounds / deep partial and full thickness burns MedDRA version: 9.1 Level: HLT Classification code 10043418 Term: Thermal burns MedDRA version: 9.1 Level: LLT Classification code 10006802 Term: Burns second degree MedDRA version: 9.1 Level: LLT Classification code 10006803 Term: Burns third degree
Conditions
Interventions
Product Code: I-020502 (0.1 microgram TG-PDGF.AB per mL fibrin)
Pharmaceutical Form: Cutaneous spray, solution
Current Sponsor code: TG-PDGF.AB
Concentration unit: µg/ml microgram(s)/millilitre
Concen
Sponsors
Kuros Biosurgery AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent by the patient. 2. Male or female patients, aged = 18 years. 3. Female with childbearing potential with a negative pregnancy test within 10 days prior to surgery who agrees to use an acceptable birth control method (hormonal or UID) until day 28 post surgery. 4. Patients with burn wound(s) up to 50% TBSA elected for autologous mesh grafting of a meshing ratio 1:3. 5. Patients with a deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA. 6. Patients who are considered to be able to comply with the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant or breast-feeding. 2. Patients with known or suspected allergies to any of the components of I-020502 (e.g. hypersensitivity to bovine proteins). 3. Digits, head, genitalia, palms of hands, soles of feet, and face as test sites. 4. Electrical and/or chemical burns. 5. Clinically significant infections at wound sites. 6. Clinically significant systemic infections. 7. History or suspicion or presence of systemic or local cancer or tumor of any kind. 8. Patients previously treated with PDGF. 9. Patients with vascular or skin disorders that directly affect the designated wound site. 10. Patients with HbA1c < 7%. 11. Patients with chronic malnourishment. 12. Chronic treatment with immunosuppressive drugs, systemic corticosteroids or other chronic treatments influencing wound healing within the last 2 months prior to surgery. 13. Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation. 14. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within 3 months prior to surgery for investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of I-020502 on the incidence of wound closure in patients with deep partial thickness or full thickness burns undergoing autologous meshed skin grafting. ;Secondary Objective: To assess the safety and tolerability of I-020502. To assess PDGF-AB levels and PDGF-AB / TG-PDGF.AB antibodies. To assess quality of life and collect pharmacoeconomic information. ;Primary end point(s): Incidence of full wound closure at each test site on Day 12. | — |
Countries
Germany
Outcome results
None listed