Status:
COMPLETED
Safety and Efficacy of I-020502 in Meshed Skin Autografting
Lead Sponsor:
Kuros Biosurgery AG
Collaborating Sponsors:
Baxter BioScience
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples ap...
Eligibility Criteria
Inclusion
- Written informed consent by the patient or his/her legal representative.
- Male or female, aged ≥ 18 years.
- Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
- Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
- 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 cm2.
- Patients who are willing to comply with treatment applications and instructions by the protocol.
Exclusion
- Females who are pregnant or breast-feeding.
- Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
- Electrical and/or chemical burns.
- Patients that are judged to have significant pulmonary compromise.
- Transcutaneous tissue oxygenation \< 90%.
- Clinically significant infections at wound sites.
- Clinically significant systemic infections.
- Suspicion or presence of active systemic or local cancer or tumor of any kind.
- Patients with known immunodeficiency disorders, either congenital or acquired.
- Patients with vascular or skin disorders that directly affect the designated wound site.
- Patients with Diabetes mellitus.
- Patients with chronic malnourishment.
- Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
- Any other acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to skin mesh grafting and study participation.
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00471939
Start Date
April 1 2007
End Date
January 1 2009
Last Update
March 3 2009
Active Locations (1)
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1
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
Bochum, Germany, 44789