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
  Purpose

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.


Condition
Transplantation Infection
Wound of Skin
Burns
Graft Loss
Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Split Thickness Skin Graft Take and Microbiology Evaluation in Burned Patients

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Estimated Enrollment: 30
Study Start Date: October 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ACUTE BURNED PATIENTS

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301118

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: ALFREDO GRAGNANI, MD PhD UFSaoPaulo
Study Chair: LYDIA M FERREIRA, MD Full Prof UFSaoPaulo
  More Information

No publications provided

Responsible Party: ALFREDO GRAGNANI FILHO, Associated Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01301118     History of Changes
Other Study ID Numbers: Graft take in burns
Study First Received: February 22, 2011
Last Updated: January 7, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Transplantation Infection
Wound of skin
Burns
Graft Loss
Infection

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 09, 2014