Evaluating MMPs in Burns

Terminated

• Conditions: Burns; Thermal Injury; Thermal Burn
• Interventions: Procedure: Graft

• Registration Number: NCT03148977
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-06-09
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients admitted to the burn center	Graft	Patients admitted to the Burn Service with acute burn injuries requiring at least one surgical excision and grafting operation.

Primary Outcome Measures

Name	Time	Method
Predictability of graft take	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 Outcome Measures

Name	Time	Method
Wound healing	2 years	Assess the predictive value of serial MMP assays in identifying wounds transitioning from likely-to-fail to likely-to-succeed

Trial Locations

Locations (2)

UF Health Shands at the University of Florida; 🇺🇸 Gainesville, Florida, United States

UF Health Cancer Hospital; 🇺🇸 Gainesville, Florida, United States