Safety and Efficacy of I-020502 in Meshed Skin Autografting

This study has been completed.
Sponsor:
Collaborator:
Baxter BioScience
Information provided by:
Kuros Biosurgery AG
ClinicalTrials.gov Identifier:
NCT00471939
First received: May 9, 2007
Last updated: March 2, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Burns
Drug: I-020502
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:
  • Incidence of treatment-related adverse events up to 28 days post surgery [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: January 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: I-020502
    1 mcg/mL TG-PDGF.AB
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ≥ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471939

Locations
Germany
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
Bochum, Germany, 44789
Sponsors and Collaborators
Kuros Biosurgery AG
Baxter BioScience
Investigators
Principal Investigator: Marcus Lehnhardt, Dr. Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
  More Information

No publications provided

Responsible Party: Virginia Jamieson, Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00471939     History of Changes
Other Study ID Numbers: CS I-020502/01
Study First Received: May 9, 2007
Last Updated: March 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kuros Biosurgery AG:
Burn, Meshed skin graft, PDGF
deep partial thickness or full thickness burns

ClinicalTrials.gov processed this record on October 19, 2014