Safety and Efficacy of I-020502 in Meshed Skin Autografting

Burns Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471939
• Other study ID #: CS I-020502/01
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2007
• Last updated: March 2, 2009
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Kuros Biosurgery AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• I-020502
1 mcg/mL TG-PDGF.AB

Locations

Country	Name	City	State
Germany	Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Kuros Biosurgery AG	Baxter BioScience

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events up to 28 days post surgery		28 days	Yes
Secondary	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	Yes