Graft Take and Microbiology in Burns

This study has suspended participant recruitment.
(Technical problems with protocol.)
Sponsor:
Information provided by (Responsible Party):
ALFREDO GRAGNANI FILHO, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01301118
First received: February 22, 2011
Last updated: January 7, 2012
Last verified: January 2012

February 22, 2011
January 7, 2012
October 2010
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Complete list of historical versions of study NCT01301118 on ClinicalTrials.gov Archive Site
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Graft Take and Microbiology in Burns
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.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

ACUTE BURNED PATIENTS

  • Transplantation Infection
  • Wound of Skin
  • Burns
  • Graft Loss
  • Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
30
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Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01301118
Graft take in burns
Yes
ALFREDO GRAGNANI FILHO, Federal University of São Paulo
Federal University of São Paulo
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Principal Investigator: ALFREDO GRAGNANI, MD PhD UFSaoPaulo
Study Chair: LYDIA M FERREIRA, MD Full Prof UFSaoPaulo
Federal University of São Paulo
January 2012

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