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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-Pdf/Gbb 0.01% gel | Drug | rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete healing of the third degree burn wound. | 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in general condition of the study subjects without any complications. | 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ratna Grewal, MD | American Scitech International- eCRO | Study Chair |
| Nani E Mansour, MD | Saint Barnabas Medical Center, The Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint. Barnabas Medical Center, The Burn Center | Livingston | New Jersey | 07039 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D002058 | Burns, Electric |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D004556 | Electric Injuries |
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| ID | Term |
|---|---|
| D005782 | Gels |
| D020571 | Genes, sis |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| D011519 |
| Proto-Oncogenes |
| D009857 | Oncogenes |
| D052138 | Genes, Neoplasm |
| D005796 | Genes |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |