Efficacy of rhPDGF-BB in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
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 (rhPDGF-BB) 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 rhPDGF-BB 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.
Description
The rhPDGF-BB 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 rhPDGF-BB gel in treating wounds caused by III degree thermal and electrical burns.
HYPOTHESIS 1: That the applications of rhPDGF-BB 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 rhPDGF-BB 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 rhPDGF-BB 0.01% gel applied once daily.
Study Design
Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Burns
Intervention
rhPDGF 0.01% gel
Location
Saint. Barnabas Medical Center, The Burn Center
Livingston
New Jersey
United States
07039
Status
Not yet recruiting
Source
American Scitech International
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00812513
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Burns
Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.
Burns, Inhalation
Burns of the respiratory tract caused by heat or inhaled chemicals.
Burns, Electric
Burns produced by contact with electric current or from a sudden discharge of electricity.
Electric Injuries
Injuries caused by electric currents. The concept excludes electric burns (BURNS, ELECTRIC), but includes accidental electrocution and electric shock.
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