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Evaluating MMPs in Burns

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ClinicalTrials.gov Identifier: NCT03148977
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 60 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 : June 9, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Group/Cohort 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Wound healing [ Time Frame: 2 years ]
    Assess the predictive value of serial MMP assays in identifying wounds transitioning from likely-to-fail to likely-to-succeed


Biospecimen Retention:   Samples With DNA
Acute burn wound exudate Acute burn wound tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult burn patients admitted
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148977


Contacts
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Contact: Joshua S. Carson, MD (352) 273-5670 Joshua.carson@surgery.ufl.edu
Contact: Tera G. Thigpin (352) 273-5670 Tera.thigpin@surgery.ufl.edu

Locations
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United States, Florida
UF Health Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Joshua S. Carson, MD    352-273-5670    Joshua.carson@surgery.ufl.edu   
Contact: Tera G. Thigpin    (352) 273-5670    Tera.thigpin@surgery.ufl.edu   
Principal Investigator: Joshua S. Carson, MD         
Sub-Investigator: David W. Mozingo, MD         
Sub-Investigator: Gregory Schultz, PhD         
Sub-Investigator: Daniel Gibson, PhD         
UF Health Shands at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Joshua S. Carson, MD    352-273-5670    Joshua.carson@surgery.ufl.edu   
Contact: Tera G. Thigpin    (352) 273-5670    Tera.thigpin@surgery.ufl.edu   
Principal Investigator: Joshua S. Carson, MD         
Sub-Investigator: David W. Mozingo, MD         
Sub-Investigator: Gregory Schultz, PhD         
Sub-Investigator: Daniel Gibson, PhD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Joshua S. Carson, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03148977    
Other Study ID Numbers: IRB201602508
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Matrix Metalloproteinases
Additional relevant MeSH terms:
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Burns
Wounds and Injuries