Transplantation InfectionNCT01301118
Graft Take and Microbiology in Burns
An observational study of Transplantation Infection and Wound of Skin, run by Federal University of São Paulo.
Trial summary
SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation Infection, Wound of Skin, Burns
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACUTE BURNED PATIENTS
Who may be able to join
- Both gender
- More than 18 years of age
- Burned patient
- Inpatient of Burn Center of Federal University of São Paulo
- Upper 5% of TBSA
- Debridement and skin graft indication and procedure realization
Who cannot join
- Not interest in participating in research
- Not have debridement or graft indication
- Under 5% of TBSA
- Skin disease
- Clinical disease that contraindication procedure
- Clinical disease that directly interferes with infectious process and wound healing
About this study
Official title: Split Thickness Skin Graft Take and Microbiology Evaluation in Burned Patients
SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS
INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates.
Read more
PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.
METHODS: This project will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected to characterize demographic and clinical aspects. Data analysis will be performed using Student's t-test and Friedman analysis of variance.
Read the detailed description
SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS
INTRODUCTION: Early excision and partial skin graft is state-of-the-art in burns treatment. Otherwise, infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates. This difference is related to moderate sensibility of cultures in general. Precise bacterial diagnostic and its susceptibility to specific antibiotics are prerequisite for adequate treatment of burn patients and skin graft integration.
PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.
METHODS: This project was approved at Ethics Committee at Federal University of São Paulo (1272/10). It will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Thirty patients will be included in this study after reading and signing a consent form. Data will be collected using an evaluation sheet to characterize demographic and clinical aspects, including partial skin graft integration, use of topical and systemic antibiotics and infection rates in all sites (blood, urine, skin, tracheal aspirate and bronchial lavage). Data analysis will be performed using Student's t-test and Friedman analysis of variance.
- Conditions
- Transplantation Infection, Wound of Skin, Burns, Graft Loss, Infection
- Keywords
- Transplantation Infection, Wound of skin, Burns, Graft Loss, Infection
- Medical subject headings
- Burns, Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startOct 2010
Why it stopped: Technical problems with protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
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, MD PhD, Principal investigator, UFSaoPauloLYDIA M FERREIRA, MD Full Prof, Study chair, UFSaoPaulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301118
- Sponsor's protocol ID
- Graft take in burns
- Status last verified
- Jan 2012
- First submitted
- 22 Feb 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Thickness Skin Graft Take and Microbiology Evaluation in Burned Patients
- ClinicalTrials.gov ID
- NCT01301118
- Acronym / sponsor ID
- Graft take in burns
- Conditions
- Transplantation Infection, Wound of Skin, Burns, Graft Loss, Infection
- Keywords
- Transplantation Infection, Wound of skin, Burns, Graft Loss, Infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Technical problems with protocol.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 23 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.
SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS
INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates.
PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.
METHODS: This project will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected to characterize demographic and clinical aspects. Data analysis will be performed using Student's t-test and Friedman analysis of variance.
Detailed description
SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS
INTRODUCTION: Early excision and partial skin graft is state-of-the-art in burns treatment. Otherwise, infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates. This difference is related to moderate sensibility of cultures in general. Precise bacterial diagnostic and its susceptibility to specific antibiotics are prerequisite for adequate treatment of burn patients and skin graft integration.
PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.
METHODS: This project was approved at Ethics Committee at Federal University of São Paulo (1272/10). It will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Thirty patients will be included in this study after reading and signing a consent form. Data will be collected using an evaluation sheet to characterize demographic and clinical aspects, including partial skin graft integration, use of topical and systemic antibiotics and infection rates in all sites (blood, urine, skin, tracheal aspirate and bronchial lavage). Data analysis will be performed using Student's t-test and Friedman analysis of variance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACUTE BURNED PATIENTS
Key inclusion criteria (6 listed)
- Both gender
- More than 18 years of age
- Burned patient
- Inpatient of Burn Center of Federal University of São Paulo
- Upper 5% of TBSA
Key exclusion criteria (6 listed)
- Not interest in participating in research
- Not have debridement or graft indication
- Under 5% of TBSA
- Skin disease
- Clinical disease that contraindication procedure
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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, MD PhD principal investigator
UFSaoPaulo
LYDIA M FERREIRA, MD Full Prof study chair
UFSaoPaulo
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation Infection and Wound of Skin, run by Federal University of São Paulo.
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 6 inclusion and 6 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: paused, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 10 Jan 2012.