Status:
UNKNOWN
Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
Lead Sponsor:
American Scitech International
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Burns
Electric Burns
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet derived growth factor (R...
Detailed Description
The R-Pdf/Gbb is recombinant human platelet-derived growth factor. It has been demonstrated that rhPDGF is effective in enhancing wound healing. OBJECTIVE: The primary objective of the study is to de...
Eligibility Criteria
Inclusion
- Patients willing to sign Informed consent.
- Patients of both genders.
- Patients between ages of 18 to 75 years.
- Patients having third degree wounds caused by thermal and electrical burns.
- Patients not willing to undergo skin grafting.
- Patients with multiple wounds are considered but each burn wound surface area will be less than 1-8 cm2.
- Wounds with adequate perfusion as assessed with the help of laser Doppler flowmeter.
Exclusion
- Patient refuses to sign informed consent.
- Burnt wounds severity less/more than III degree (i.e. I, II, IV degree burns).
- Patients having known neoplasm at the site of application.
- Patients with low serum proteins.
- Patients with uncontrolled hyperglycemia.
- Patients who are taking Ibuprofen.
- Patients with known hypersensitivity to parabens.
- All other burns except thermal and electrical burns.
- Neurological or psychiatric pathologies.
- Women who are pregnant or nursing and women of child bearing age, who are not taking contraceptives or not willing to use them for the period of treatment.
- Local or systemic infection
- Conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00812513
Start Date
July 1 2011
End Date
April 1 2012
Last Update
July 20 2011
Active Locations (1)
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1
Saint. Barnabas Medical Center, The Burn Center
Livingston, New Jersey, United States, 07039