Clinical trial NCT01302223: Keratinocyte Growth Factor and Cytokines in Burns.
Official title: Keratinocyte Growth Factor, Interleukin 1 Beta, 6, 8, 10, 12 and Tumor Necrosis Factor Alpha in Burned Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Growth Factors, Combined Defect of
Inflammation
Cytokine Storm
Keywords: burns
Growth Factors, Combined Defect of
inflammation
Cytokine Storm
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACUTE BURNED PATIENTS

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Keratinocyte Growth Factor
timeFrame: cultured cells at second passage
Secondary outcomes:
measure: Interleucin 1 beta, 6, 8, 10, 12 and tumor necrosis factor alfa
timeFrame: cultured fibroblasts at second passage
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Burn Center of Federal University of Sao Paulo
Study officials:
affiliation: UFSaoPaulo
name: ALFREDO GRAGNANI FILHO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UFSaoPaulo
name: LYDIA M FERREIRA, MD Full Prof
role: STUDY_CHAIR
References: