Evaluating MMPs in Burns

Sponsor

University of Florida (Other)

Overall Status

Terminated

CT.gov ID

NCT03148977

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Thermal Burn Thermal Injury	Procedure: Graft

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 Design

Study Type:

Observational

Actual Enrollment :

8 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 9, 2017

Actual Primary Completion Date :

Dec 8, 2020

Actual Study Completion Date :

Dec 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients admitted to the burn center Patients admitted to the Burn Service with acute burn injuries requiring at least one surgical excision and grafting operation.	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.

Arm

Intervention/Treatment

Patients admitted to the burn center

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 98 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health Cancer Hospital	Gainesville	Florida	United States	32608
2	UF Health Shands at the University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Joshua S. Carson, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT03148977

Other Study ID Numbers:

IRB201602508

First Posted:

May 11, 2017

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Florida

Matrix Metalloproteinases

Additional relevant MeSH terms:

Burns

Study Results

No Results Posted as of Mar 26, 2021