A Study to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand

Conditions
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Partial Thickness Burn of Hand

Intervention / Treatment
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* Device: Cytal® Burn Matrix
* Device: EZ-Derm® Porcine Xenograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-site, randomized, prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Cytal® Burn Matrix | Device: Cytal® Burn Matrix<br>* Cytal® Burn Matrix<br>|
| Active Comparator: Group 2<br>EZ-Derm® Porcine Xenograft | Device: EZ-Derm® Porcine Xenograft<br>* EZ-Derm® Porcine Xenograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Wound Healing | To Compare the time to complete wound healing between Groups 1 and 2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months | 
| Wound Infections | The total number of burn wound infections between Group 1 and 2 | 21 days | 
| Rate of Healing | Measured by change in wound surface area over time, in cm2/week between Groups 1 and 2. | 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. | 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. | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACell, Hand, Burn, ACell Cytal Burn Matrix®, Extracellular Matrix, Urinary Bladder Matrix, Wound, Partial-Thickness, Burn Management