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

Primary Purpose

Burns, Electric Burns

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

R-Pdf/Gbb 0.01% gel

About this trial

This is an interventional treatment trial for Burns focused on measuring rhPDGF-BB, Platelet derived growth factor, Burns, Thermal burns, Electric burns

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Saint. Barnabas Medical Center, The Burn Center

Outcomes

Primary Outcome Measures

Complete healing of the third degree burn wound.

Secondary Outcome Measures

Improvement in general condition of the study subjects without any complications.

Full Information

NCT ID

NCT00812513

First Posted

December 19, 2008

Last Updated

July 19, 2011

Sponsor

American Scitech International

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT00812513

Brief Title

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

Official Title

Phase II Study of Efficacy of Recombinant Human Platelet-derived Growth Factor (R-Pdf/Gbb) in Healing Wounds Caused by Third Degree Thermal and Electrical Burns.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

American Scitech International

Collaborators

Johnson & Johnson

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns, Electric Burns

Keywords

rhPDGF-BB, Platelet derived growth factor, Burns, Thermal burns, Electric burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

R-Pdf/Gbb 0.01% gel

Other Intervention Name(s)

Recombinant human platelet-derived growth factor

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete healing of the third degree burn wound.

Time Frame

3 months.

Secondary Outcome Measure Information:

Title

Improvement in general condition of the study subjects without any complications.

Time Frame

3 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ratna Grewal, MD

Organizational Affiliation

American Scitech International- eCRO

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Nani E Mansour, MD

Organizational Affiliation

Saint Barnabas Medical Center, The Burn Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint. Barnabas Medical Center, The Burn Center

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nani E Mansour, MD

Phone

908-941-5480

rgreywal@americanscitech.com

First Name & Middle Initial & Last Name & Degree

Ratna Grewal, MD

Phone

908-941-5480

rgreywal@americanscitech.com

12. IPD Sharing Statement

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

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