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NCT03148977 Clinical Trial

Evaluating MMPs in Burns

Burns Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03148977
Other study ID # IRB201602508
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 9, 2017
Est. completion date December 8, 2020

Study information
Verified date March 2021
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 98 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Graft
Autogenous skin grafting is the only definitive treatment for the full thickness burn injuries, and thus represents the centerpiece of modern burn care.

Locations
Country Name City State
United States UF Health Cancer Hospital Gainesville Florida
United States UF Health Shands at the University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Predictability of graft take 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. 2 years
Secondary Wound healing Assess the predictive value of serial MMP assays in identifying wounds transitioning from likely-to-fail to likely-to-succeed 2 years
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