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Keratinocyte Growth Factor, Interleukin 1 Beta, 6, 8, 10, 12 and Tumor Necrosis Factor Alpha in Burned Patients.


N/A
18 Years
50 Years
Not Enrolling
Both
Burns, Growth Factors, Combined Defect of, Inflammation, Cytokine Storm

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Trial Information

Keratinocyte Growth Factor, Interleukin 1 Beta, 6, 8, 10, 12 and Tumor Necrosis Factor Alpha in Burned Patients.


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.

Key words: burns, cytokines, inflammation, keratinocyte growth factor, fibroblasts.


Inclusion Criteria:



- 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)

Exclusion Criteria:

- Not interest in participating in research

- Not acceptance of surgical procedure

- Previous Skin disease

- Clinical disease that directly interferes with wound healing

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Keratinocyte Growth Factor

Outcome Description:

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

Outcome Time Frame:

cultured cells at second passage

Safety Issue:

Yes

Principal Investigator

ALFREDO GRAGNANI FILHO, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UFSaoPaulo

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

KGF and Cytokines in Burns

NCT ID:

NCT01302223

Start Date:

October 2011

Completion Date:

December 2012

Related Keywords:

  • Burns
  • Growth Factors, Combined Defect of
  • Inflammation
  • Cytokine Storm
  • burns
  • Growth Factors, Combined Defect of
  • inflammation
  • Cytokine Storm
  • Burns
  • Inflammation

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