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Clinical Trials/NCT03148977
NCT03148977
Terminated
Not Applicable

Evaluating a Point-of-Care, Quantitative Matrix Metalloproteinase Assay as a Predictor of Successful Graft Take in Patients Undergoing Cutaneous Auto Grafting for Acute Burn Injury- A Pilot Study

University of Florida2 sites in 1 country8 target enrollmentJune 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burns
Sponsor
University of Florida
Enrollment
8
Locations
2
Primary Endpoint
Predictability of graft take
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

The objective of this study is to determine whether our chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

Detailed Description

This is an observational pilot study of patients treated at UF Health Shands Burn Center adult service. This is a study to determine the predictive value of quantifying concentrations of specific MMPs. Coupling this with a specialized collection sample collection system and a calibrated fluorimetry allows for the rapid assessment of MMP concentrations. This assay has been validated as a predictor of failed wound healing in a published clinical study involving chronic open wounds.

Registry
clinicaltrials.gov
Start Date
June 9, 2017
End Date
December 8, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • Admitted with acute burns injuries (flame, contact or scald) requiring at least one surgical excision and grafting operation will be considered for inclusion
  • Burn injury less than one week old

Exclusion Criteria

  • Electrical, chemical or cold-induced burn injury
  • Total body surface area burn \>50 %
  • Pre injury diagnosis of chronic renal insufficiency, liver failure, refusal to accept blood transfusion or withdrawal of care within three days of admission will also be exclusion criteria
  • Patients not expected to survive
  • Patients presenting with re-injury to previously burned and treated areas.
  • Patients who present after receiving burn excision surgery out an outside facility for the current acute injury

Outcomes

Primary Outcomes

Predictability of graft take

Time Frame: 2 years

Determine whether chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

Secondary Outcomes

  • Wound healing(2 years)

Study Sites (2)

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