NCT01301118

Brief 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.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for all trials

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

First QC Date

February 22, 2011

Last Update Submit

January 7, 2012

Conditions

Keywords

Transplantation InfectionWound of skinBurnsGraft LossInfection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACUTE BURNED PATIENTS

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BurnsInfections

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • ALFREDO GRAGNANI, MD PhD

    UFSaoPaulo

    PRINCIPAL INVESTIGATOR
  • LYDIA M FERREIRA, MD Full Prof

    UFSaoPaulo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

October 1, 2010

Last Updated

January 10, 2012

Record last verified: 2012-01