Deep partial-thickness and full-thickness burns require grafting procedures to achieve wound healing and closure. Autologous grafting eliminates the risk of transmissible diseases but may be complicated by hematoma formation, infection and mechanical disruption. In large total body surface area burns, the skin donor site is quickly exhausted. Meshed skin autografts become a convenient alternative for which the use of I-020502 will be investigated. MedDRA version: 8.1 Level: LLT Classification c
Conditions
Interventions
Product Name: WHG I-020502
Product Code: I-020502
Pharmaceutical Form: Gel
Sponsors
KUROS BIOSURGERY AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent by the patient or his/her legal representative. 2.Male or female, aged = 18 years 3.Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening). 4.Patients with burn wound(s) between = 10 % and = 30 % TBSA. 5.Patients with a contiguous 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 but not more than 400 sqcm. 6.Patients who are willing to comply with treatment applications and instructions by 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 the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins). 3.Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites. 4.Electrical and/or chemical burns. 5.Patients that are judged to have significant pulmonary compromise. 6.Transcutaneous tissue oxygenation < 90%. 7.Clinically significant infections at wound sites. 8.Clinically significant systemic infections. 9.Suspicion or presence of active systemic or local cancer or tumor of any kind. 10.Patients with known immunodeficiency disorders, either congenital or acquired. 11.Patients with vascular or skin disorders that directly affect the designated wound site. 12.Patients with Diabetes mellitus. 13.Patients with chronic malnourishment. 14.Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery. 15.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion are a contraindication to skin mesh grafting and study participation. 16.Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability and safety of I-020502 on wound healing in patients with deep partial thickness or full thickness burns undergoing autologous meshed skin grafting.;Secondary Objective: To assess the efficacy of I-020502 on wound healing and wound closure at the site of the mesh graft, including scar evaluation.;Primary end point(s): Incidence of treatment-related adverse events, systemic and at the test sites, up to Day 28 after surgery. | — |
Countries
Germany
Outcome results
None listed