Partial Thickness Burn of HandNCT03598023
A Study to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
A study testing Cytal® Burn Matrix and EZ-Derm® Porcine Xenograft in people with Partial Thickness Burn of Hand, run by Integra LifeSciences Corporation.
Trial summary
This is a randomized controlled trial (RCT) aimed at determining if use of Cytal® Burn Matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to EZ-Derm Porcine Xenograft. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial Thickness Burn of Hand
- What is being tested?
- Cytal® Burn Matrix and EZ-Derm® Porcine Xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to 31 Dec 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female, 18 to 75 years of age.
- Negative pregnancy test required.
- Presence of partial thickness burns to one or both hands.
- Thermal burn etiology.
Who cannot join
- Allergy or hypersensitivity to materials in porcine-based study products or personal preference.
- Friction, chemical, or electric burn etiology.
- Immunosuppression.
- Presence of a local and/or systemic infection.
- Received prior treatment to the study site within 60 days of Screening.
- Concurrent participation in another clinical trial.
About this study
Official title: A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
This is a randomized controlled trial (RCT) aimed at determining if use of Cytal® Burn Matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to EZ-Derm Porcine Xenograft.
Read the detailed description
A single site, two arm, parallel-design randomized trial comparing Cytal® Burn Matrix to EZ-Derm® Porcine Xenograft, for patients with partial-thickness burns to the hand. Up to 60 patients from a single center will be recruited and randomized (using a 1:1 randomization scheme) to receive either Cytal® Burn Matrix or EZ-Derm®. Scar formation, number of wounds requiring autografting, wound infections, rate of healing, hand function and impact of treatment will be compared between study arms. Additionally, a cost analysis and review of individual and group changes in narcotic prescription patterns and employment status will be evaluated. The protocol defined patient follow-up is 6 months.
An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee will adjudicate adverse events (AEs) and serious adverse events (SAEs)
- Conditions
- Partial Thickness Burn of Hand
- Being tested
- Cytal® Burn Matrix, EZ-Derm® Porcine Xenograft
- Keywords
- ACell, Hand, Burn, ACell Cytal Burn Matrix®, Extracellular Matrix, Urinary Bladder Matrix, Wound, Partial-Thickness, Burn Management
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytal® Burn MatrixDevice
Cytal® Burn Matrix
EZ-Derm® Porcine XenograftDevice
EZ-Derm® Porcine Xenograft
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Cytal® Burn Matrix Receives: Device: Cytal® Burn Matrix |
| Group 2 | Active comparator | EZ-Derm® Porcine Xenograft Receives: Device: EZ-Derm® Porcine Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Healing
To Compare the time to complete wound healing between Groups 1 and 2
Measured: 6 months
Secondary outcomes (7)
Evaluation of Scar Formation
To assess, measure, and evaluate scar formation between Groups 1 and Group 2 using Vancouver Scar Scale (VSS). VSS is a scale from 0 (normal) to 13 on an index scale measuring pigmentation, pliability, height, vascularity, pain and pruritus.
Measured: 6 months
Wounds Requiring Autografting
The total number of wounds that required the use of autografting by 6 months will be compared between Groups 1 and 2.
Measured: 6 months
Wound Infections
The total number of burn wound infections between Group 1 and 2
Measured: 21 days
Rate of Healing
Measured by change in wound surface area over time, in cm2/week between Groups 1 and 2.
Measured: 6 months
Hand Function
Hand function measured by Michigan Hand Scale, Quick DASH and occupational therapy evaluation
MHQ measures overall hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction. The score ranges from 0 (worst) to 100 (best) performances and satisfaction. Pain ranges from 0(no pain) to 100 (worst pain).
Quick DASH uses a 5 point Likert scale with 0(no disability) to 5(most severe disability) to measure disability/symptom and sport/music performance or work modules.
Measured: 6 months
Impact of Treatment
Pain assessment using Visual Analog Pain Scale (VAS) and inpatient length of stay. VAS measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a vertical line on a 10 cm horizontal line indicating what their current pain level would be with 0 being no pain and 10 being the worst pain imaginable. The distance between the start of the horizontal line to the vertical line is calculated in cm.
Measured: 6 months
Compare treatment-emergent adverse event safety profile between Group 1 and Group 2
Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Effects (UADEs) between Group 1 and 2. AEs being any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. SAEs being any suspected adverse reaction considered "serious" by the Investigator or Sponsor. UADEs being any serious adverse effect associated with the device that affects the rights, safety, or welfare of subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2018 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Sponsor discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness Burn of HandStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-site, randomized, prospective study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Blair Summitt, MD, Principal investigator, Vanderbilt University Medical Center, Regional Burn CenterWesley Thayer, MD, Principal investigator, Vanderbilt University Medical Center, Regional Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598023
- Sponsor's protocol ID
- CR2017-001
- Status last verified
- Mar 2021
- First submitted
- 21 May 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
- ClinicalTrials.gov ID
- NCT03598023
- Acronym / sponsor ID
- CR2017-001
- Conditions
- Partial Thickness Burn of Hand
- Keywords
- ACell, Hand, Burn, ACell Cytal Burn Matrix®, Extracellular Matrix, Urinary Bladder Matrix, Wound, Partial-Thickness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- Aug 2018 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Jul 2018 (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.
This is a randomized controlled trial (RCT) aimed at determining if use of Cytal® Burn Matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to EZ-Derm Porcine Xenograft.
Detailed description
A single site, two arm, parallel-design randomized trial comparing Cytal® Burn Matrix to EZ-Derm® Porcine Xenograft, for patients with partial-thickness burns to the hand. Up to 60 patients from a single center will be recruited and randomized (using a 1:1 randomization scheme) to receive either Cytal® Burn Matrix or EZ-Derm®. Scar formation, number of wounds requiring autografting, wound infections, rate of healing, hand function and impact of treatment will be compared between study arms. Additionally, a cost analysis and review of individual and group changes in narcotic prescription patterns and employment status will be evaluated. The protocol defined patient follow-up is 6 months.
An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee will adjudicate adverse events (AEs) and serious adverse events (SAEs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-site, randomized, prospective study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Cytal® Burn MatrixCytal® Burn Matrix |
| Group 2 | Active comparator | Device: EZ-Derm® Porcine XenograftEZ-Derm® Porcine Xenograft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female, 18 to 75 years of age.
- Negative pregnancy test required.
- Presence of partial thickness burns to one or both hands.
- Thermal burn etiology.
Key exclusion criteria (6 listed)
- Allergy or hypersensitivity to materials in porcine-based study products or personal preference.
- Friction, chemical, or electric burn etiology.
- Immunosuppression.
- Presence of a local and/or systemic infection.
- Received prior treatment to the study site within 60 days of Screening.
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 |
|---|---|---|
| Cytal® Burn MatrixCytal® Burn Matrix | Device | Group 1 |
| EZ-Derm® Porcine XenograftEZ-Derm® Porcine Xenograft | Device | Group 2 |
Primary outcome
Time to Complete Wound Healing
Time frame: 6 months
To Compare the time to complete wound healing between Groups 1 and 2
7 secondary outcomes
Evaluation of Scar Formation
Time frame: 6 months
Wounds Requiring Autografting
Time frame: 6 months
Wound Infections
Time frame: 21 days
Rate of Healing
Time frame: 6 months
Hand Function
Time frame: 6 months
Impact of Treatment
Time frame: 6 months
Compare treatment-emergent adverse event safety profile between Group 1 and Group 2
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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.
Blair Summitt, MD principal investigator
Vanderbilt University Medical Center, Regional Burn Center
Wesley Thayer, MD principal investigator
Vanderbilt University Medical Center, Regional Burn Center
Questions about this trial
What is this clinical trial studying?
A study testing Cytal® Burn Matrix and EZ-Derm® Porcine Xenograft in people with Partial Thickness Burn of Hand, run by Integra LifeSciences Corporation.
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 4 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: withdrawn, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Time to Complete Wound Healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.