Keratinocyte Growth Factor and Cytokines in Burns.

NCT01302223 | Completed DMC

• 1 other identifier: KGF and Cytokines in Burns
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

KERATINOCYTE GROWTH FACTOR AND CYTOKINES IN SKIN BURNS. INTRODUCTION: Intense inflammatory responses are activated by burns that affect a large total body surface area. Changes in plasma levels of cytokines after burns occur before metabolic abnormalities unsettle the patient. So it may be possible to develop therapeutic interventions that may attenuate the acute inflammatory response by decreasing the expression of these cytokines. The importance of growth factors in the healing process was demonstrated in cultured keratinocytes and fibroblasts. The keratinocyte growth factor (KGF) is a growth factor active in the repair of wounds, being the most potent stimulator of mitotic cells. PURPOSE: To assess the level of keratinocyte growth factor (KGF) and IL-1ß, IL-6, IL-8, IL-10, IL-12 and TNF-alfa of patients with burns produced by cultured primary dermal fibroblasts and the gene expression. METHODS: 10 patients will be include (05 patients in the study group and 05 patients in the control group) admitted to the Burns Care Unit of the Discipline of Plastic Surgery, Federal University of São Paulo (UNIFESP) between 25% and 50% of total body surface area (TBSA), deep second-degree or third degree, with need to perform surgical debridement. The control group will be constituted by patients with less than 5% of TBSA, deep second-degree or third degree, with need to perform surgical debridement. The authors will evaluate the levels of IL-1ß, IL-6, IL-8, IL-10, IL-12p70 and tumor necrosis factor alpha (TNF-alfa) in samples of the culture media of primary dermal fibroblasts of patients selected using flow cytometry. The level of keratinocyte growth factor (KGF), in the same samples will be evaluated by ELISA. The keratinocyte growth factor (KGF) and TNF-alfa gene expression will be evaluated in the culture of primary dermal fibroblasts from the same patients. The gene expression of KGF and cytokines will be done by qRT-PCR and RT-PCR array. The experiments will be done in duplicate.

Conditions

Burns; Growth Factors, Combined Defect of; Inflammation; Cytokine Storm

Keywords

burns; Growth Factors, Combined Defect of; inflammation; Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• Keratinocyte Growth Factor

  Level of KGF in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.

  cultured cells at second passage

Secondary Outcomes (1)

• Interleucin 1 beta, 6, 8, 10, 12 and tumor necrosis factor alfa

  cultured fibroblasts at second passage

Study Arms (2)

Minor Burns

Total burn surface area less than 5% of second and third degree.

Major Burns.

Total Burn Surface Area more than 25% of second and third degree, and less than 50%.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ACUTE BURNED PATIENTS

You may qualify if:

• Both gender
• More than 18 years of age
• Burned patient
• Burned debridement necessary
• Inpatient of Burn Center of Federal University of São Paulo
• More than 25% and less than 50% of TBSA (group major burns)
• Less than 5% of TBSA (group minor burns)

You may not qualify if:

• Not interest in participating in research
• Not acceptance of surgical procedure
• Previous Skin disease
• Clinical disease that directly interferes with wound healing

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Burn Center of Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Normal skin will be collected at first burned patient debridment and send to Cell Culture Laboratory to start fibroblast and queratinocyte culture.

MeSH Terms

Conditions

Burns; Growth Factors, Combined Defect of; Inflammation; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Shock

Study Officials

• ALFREDO GRAGNANI FILHO, MD, PhD

  UFSaoPaulo

  PRINCIPAL INVESTIGATOR

• LYDIA M FERREIRA, MD Full Prof

  UFSaoPaulo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

BR (1)