Evaluating MMPs in Burns

NCT ID: NCT03148977

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-09

Study Completion Date

2020-12-08

Brief Summary

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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

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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.

Conditions

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Burns Thermal Burn Thermal Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Graft

Intervention Type PROCEDURE

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

Interventions

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Graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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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 %
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua S. Carson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Cancer Hospital

Gainesville, Florida, United States

Site Status

UF Health Shands at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Weigelt MA, Lev-Tov HA, Tomic-Canic M, Lee WD, Williams R, Strasfeld D, Kirsner RS, Herman IM. Advanced Wound Diagnostics: Toward Transforming Wound Care into Precision Medicine. Adv Wound Care (New Rochelle). 2022 Jun;11(6):330-359. doi: 10.1089/wound.2020.1319. Epub 2021 Jul 21.

Reference Type DERIVED
PMID: 34128387 (View on PubMed)

Other Identifiers

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IRB201602508

Identifier Type: -

Identifier Source: org_study_id

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