Clinical Trials Directory

Trials / Suspended

SuspendedNCT01301118

Graft Take and Microbiology in Burns

Split Thickness Skin Graft Take and Microbiology Evaluation in Burned Patients

Status
Suspended
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Timeline

Start date
2010-10-01
First posted
2011-02-23
Last updated
2012-01-10

Source: ClinicalTrials.gov record NCT01301118. Inclusion in this directory is not an endorsement.