BurnsNCT01302223
Keratinocyte Growth Factor and Cytokines in Burns.
An observational study of Burns and Growth Factors, Combined Defect of, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Burns, Growth Factors, Combined Defect of, Inflammation
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: ACUTE BURNED PATIENTS
Who may be able to join
- 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)
Who cannot join
- Not interest in participating in research
- Not acceptance of surgical procedure
- Previous Skin disease
- Clinical disease that directly interferes with wound healing
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Burn Center of Federal University of Sao Paulo
São Paulo, São Paulo
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- burns, Growth Factors, Combined Defect of, inflammation, Cytokine Storm
- Medical subject headings
- Burns, Growth Factors, Combined Defect of, Inflammation, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinocyte Growth Factor
Level of KGF in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.
Measured: cultured cells at second passage
Secondary outcomes (1)
Interleucin 1 beta, 6, 8, 10, 12 and tumor necrosis factor alfa
Level of cytokines in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.
Measured: cultured fibroblasts at second passage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALFREDO GRAGNANI FILHO, Federal University of São Paulo
- Investigators
- ALFREDO GRAGNANI FILHO, MD, PhD, Principal investigator, UFSaoPauloLYDIA M FERREIRA, MD Full Prof, Study chair, UFSaoPaulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302223
- Sponsor's protocol ID
- KGF and Cytokines in Burns
- Status last verified
- Dec 2012
- First submitted
- 23 Feb 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratinocyte Growth Factor, Interleukin 1 Beta, 6, 8, 10, 12 and Tumor Necrosis Factor Alpha in Burned Patients.
- ClinicalTrials.gov ID
- NCT01302223
- Acronym / sponsor ID
- KGF and Cytokines in Burns
- Keywords
- burns, Growth Factors, Combined Defect of, inflammation, Cytokine Storm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ACUTE BURNED PATIENTS
Key inclusion criteria (7 listed)
- Both gender
- More than 18 years of age
- Burned patient
- Burned debridement necessary
- Inpatient of Burn Center of Federal University of São Paulo
Key exclusion criteria (4 listed)
- Not interest in participating in research
- Not acceptance of surgical procedure
- Previous Skin disease
- Clinical disease that directly interferes with wound healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Keratinocyte Growth Factor
Time frame: cultured cells at second passage
Level of KGF in cultured fibroblasts at second passage in media culture and qRT-PCR and RT-PCR array.
1 secondary outcome
Interleucin 1 beta, 6, 8, 10, 12 and tumor necrosis factor alfa
Time frame: cultured fibroblasts at second passage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALFREDO GRAGNANI FILHO, MD, PhD principal investigator
UFSaoPaulo
LYDIA M FERREIRA, MD Full Prof study chair
UFSaoPaulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Growth Factors, Combined Defect of, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratinocyte Growth Factor (time frame: cultured cells at second passage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.