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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
History of Changes
  Purpose

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.


Condition
Burns
Growth Factors, Combined Defect of
Inflammation
Cytokine Storm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Keratinocyte Growth Factor, Interleukin 1 Beta, 6, 8, 10, 12 and Tumor Necrosis Factor Alpha in Burned Patients.

Resource links provided by NLM:

MedlinePlus related topics: Burns Cancer
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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.


Enrollment: 8
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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%.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ACUTE BURNED PATIENTS

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302223

Locations
Brazil
Burn Center of Federal University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: ALFREDO GRAGNANI FILHO, MD, PhD UFSaoPaulo
Study Chair: LYDIA M FERREIRA, MD Full Prof UFSaoPaulo
  More Information

No publications provided

Responsible Party: ALFREDO GRAGNANI FILHO, Associated Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01302223     History of Changes
Other Study ID Numbers: KGF and Cytokines in Burns
Study First Received: February 23, 2011
Last Updated: December 5, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
burns
Growth Factors, Combined Defect of
inflammation
Cytokine Storm

Additional relevant MeSH terms:
Burns
Inflammation
Wounds and Injuries
Pathologic Processes
 Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013