Safety and Efficacy of I-020502 in Meshed Skin Autografting

NCT00471939 | Completed Phase 2

• 1 other identifier: CS I-020502/01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burn, Meshed skin graft, PDGF; deep partial thickness or full thickness burns

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events up to 28 days post surgery

  28 days

Secondary Outcomes (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

  28 days

Interventions

I-020502 DRUG

1 mcg/mL TG-PDGF.AB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Baxter BioScience: collaborator

Study Sites (1)

Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte

Bochum, 44789, Germany

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Marcus Lehnhardt, Dr.

  Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: May 10, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2009
• Last Updated: March 3, 2009

Record last verified: 2009-03

Locations

DE (1)