Burns, Electric Burns
Conditions
Keywords
rhPDGF-BB, Platelet derived growth factor, Burns, Thermal burns, Electric burns
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-Pdf/Gbb) has biologic activity similar to endogenous platelet derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and proliferation of cells responsible for wound repair and it augments production of granulation tissue. The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III and IV. The nature of wounds in the third degree burns is similar so far as healing process is concerned. The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01% gel on the third degree thermal and electrical burns will heal these wounds within 3 months and there will be improvement in general condition of the patients without any complications.
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 determine the efficacy of R-Pdf/Gbb gel in treating wounds caused by III degree thermal and electrical burns. HYPOTHESIS 1: That the applications of R-Pdf/Gbb 0.01% gel on III degree thermal and electrical burns will heal these wounds within 3 months. HYPOTHESIS 2: Subjects, who having III degree thermal and electrical burns with the treatment of R-Pdf/Gbb 0.01% gel, will show improvement in general condition without any complications. We aim to test these hypotheses by evaluating the clinical outcome in about 120 patients after three months of treatment with R-Pdf/Gbb 0.01% gel applied once daily.
Interventions
DRUGR-Pdf/Gbb 0.01% gel
rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months
Sponsors
Johnson & Johnson
American Scitech International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing of the third degree burn wound. | 3 months. |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in general condition of the study subjects without any complications. | 3 months. |
Countries
United States
Outcome results
None listed