Safety and Efficacy of I-020502 in Meshed Skin Autografting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471939
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : March 3, 2009
Baxter BioScience
Information provided by:
Kuros Biosurgery AG

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

Condition or disease Intervention/treatment Phase
Burns Drug: I-020502 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Intervention Details:
  • Drug: I-020502
    1 mcg/mL TG-PDGF.AB

Primary Outcome Measures :
  1. Incidence of treatment-related adverse events up to 28 days post surgery [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471939

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

Responsible Party: Virginia Jamieson, Kuros Biosurgery AG Identifier: NCT00471939     History of Changes
Other Study ID Numbers: CS I-020502/01
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009

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