Safety and Efficacy of I-020502 in Meshed Skin Autografting

A Phase II, Multi-Centre, Controlled Study of the Safety and Efficacy of Wound Healing Gel I-020502 (KUR-212) in Patients Undergoing Autologous Meshed Skin Grafting.

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 applied in the same patient to burn areas requiring autologous meshed skin grafting.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: I-020502

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44789
    • Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥ 5 % and ≤ 50 % 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 cm2.
6. Patients who are willing to comply with treatment applications and instructions by the protocol.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-related adverse events up to 28 days post surgery	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments	28 days

Collaborators and Investigators

• Sponsor: Kuros Biosurgery AG
• Collaborators: Baxter BioScience
• Investigators: Principal Investigator: Marcus Lehnhardt, Dr., Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: May 9, 2007
• First Submitted That Met QC Criteria: May 9, 2007
• First Posted (Estimate): May 10, 2007

Study Record Updates

• Last Update Posted (Estimate): March 3, 2009
• Last Update Submitted That Met QC Criteria: March 2, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Burn, Meshed skin graft, PDGF; deep partial thickness or full thickness burns
• Other Study ID Numbers: CS I-020502/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No