Graft Take and Microbiology in Burns

January 7, 2012 updated by: ALFREDO GRAGNANI FILHO, Federal University of São Paulo

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ACUTE BURNED PATIENTS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ALFREDO GRAGNANI, MD PhD, UFSaoPaulo
  • Study Chair: LYDIA M FERREIRA, MD Full Prof, UFSaoPaulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 7, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Graft take in burns

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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