Keratinocyte Growth Factor and Cytokines in Burns.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALFREDO GRAGNANI FILHO, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01302223
First received: February 23, 2011
Last updated: December 5, 2012
Last verified: December 2012

February 23, 2011
December 5, 2012
October 2011
December 2012   (final data collection date for primary outcome measure)
Keratinocyte Growth Factor [ Time Frame: cultured cells at second passage ] [ Designated as safety issue: Yes ]
Level of KGF in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.
Not Provided
Complete list of historical versions of study NCT01302223 on ClinicalTrials.gov Archive Site
Interleucin 1 beta, 6, 8, 10, 12 and tumor necrosis factor alfa [ Time Frame: cultured fibroblasts at second passage ] [ Designated as safety issue: Yes ]
Level of cytokines in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.
Not Provided
Not Provided
Not Provided
 
Keratinocyte Growth Factor and Cytokines in Burns.
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

ACUTE BURNED PATIENTS

  • Burns
  • Growth Factors, Combined Defect of
  • Inflammation
  • Cytokine Storm
Not Provided
  • 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%.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01302223
KGF and Cytokines in Burns
Yes
ALFREDO GRAGNANI FILHO, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: ALFREDO GRAGNANI FILHO, MD, PhD UFSaoPaulo
Study Chair: LYDIA M FERREIRA, MD Full Prof UFSaoPaulo
Federal University of São Paulo
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP