BurnsNCT03148977
Evaluating MMPs in Burns
An observational study of Burns and Thermal Burn, run by University of Florida at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Burns, Thermal Burn, Thermal Injury
- What is being tested?
- Graft
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2017to 8 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult burn patients admitted
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health Cancer Hospital
Gainesville, Florida, 32608
UF Health Shands at the University of Florida
Gainesville, Florida, 32610
About this study
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
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.
Read the 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.
- Conditions
- Burns, Thermal Burn, Thermal Injury
- Being tested
- Graft
- Keywords
- Matrix Metalloproteinases
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GraftProcedure or surgery
Autogenous skin grafting is the only definitive treatment for the full thickness burn injuries, and thus represents the centerpiece of modern burn care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Wound healing
Assess the predictive value of serial MMP assays in identifying wounds transitioning from likely-to-fail to likely-to-succeed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start9 Jun 2017
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Why it stopped: IRB expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua S. Carson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148977
- Sponsor's protocol ID
- IRB201602508
- Status last verified
- Mar 2021
- First submitted
- 9 May 2017
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34128387
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03148977
- Acronym / sponsor ID
- IRB201602508
- Conditions
- Burns, Thermal Burn, Thermal Injury
- Keywords
- Matrix Metalloproteinases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB expired
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the burn center | – | Procedure: GraftPatients admitted to the Burn Service with acute burn injuries requiring at least one surgical excision and grafting operation. |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult burn patients admitted
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GraftAutogenous skin grafting is the only definitive treatment for the full thickness burn injuries, and thus represents the centerpiece of modern burn care. | Procedure or surgery | Patients admitted to the burn center |
Primary outcome
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.
1 secondary outcome
Wound healing
Time frame: 2 years
Results and safety
The study was stopped early (reason given: IRB expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 34128387Weigelt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua S. Carson, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Thermal Burn, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictability of graft take (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.