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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Burns
• Thermal Burn
• Thermal Injury

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