Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns

NCT ID: NCT00812513

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-04-30

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.

Conditions

Burns; Electric Burns

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

R-Pdf/Gbb 0.01% gel

rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months

Intervention Type: DRUG

Other Intervention Names

Recombinant human platelet-derived growth factor

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

American Scitech International

OTHER

Sponsor Role: lead

Responsible Party

American Scitech International

Principal Investigators

Ratna Grewal, MD

Role: STUDY_CHAIR

American Scitech International- eCRO

Nani E Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Barnabas Medical Center, The Burn Center

Locations

Saint. Barnabas Medical Center, The Burn Center

Livingston, New Jersey, United States

Countries

United States

Facility Contacts

Nani E Mansour, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Ratna Grewal, MD

Role: backup

rgreywal@americanscitech.com

908-941-5480

Other Identifiers

ASI-TEBII1208

Identifier Type: -

Identifier Source: org_study_id