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

Overview

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.

Full Title of Study: “A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2020

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)

Interventions

  • Device: Cytal® Burn Matrix
    • Cytal® Burn Matrix
  • Device: EZ-Derm® Porcine Xenograft
    • EZ-Derm® Porcine Xenograft

Arms, Groups and Cohorts

  • Active Comparator: Group 1
    • Cytal® Burn Matrix
  • Active Comparator: Group 2
    • EZ-Derm® Porcine Xenograft

Clinical Trial Outcome Measures

Primary Measures

  • Time to Complete Wound Healing
    • Time Frame: 6 months
    • To Compare the time to complete wound healing between Groups 1 and 2

Secondary Measures

  • Evaluation of Scar Formation
    • Time Frame: 6 months
    • 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.
  • Wounds Requiring Autografting
    • Time Frame: 6 months
    • The total number of wounds that required the use of autografting by 6 months will be compared between Groups 1 and 2.
  • Wound Infections
    • Time Frame: 21 days
    • The total number of burn wound infections between Group 1 and 2
  • Rate of Healing
    • Time Frame: 6 months
    • Measured by change in wound surface area over time, in cm2/week between Groups 1 and 2.
  • Hand Function
    • Time Frame: 6 months
    • 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.
  • Impact of Treatment
    • Time Frame: 6 months
    • 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.
  • Compare treatment-emergent adverse event safety profile between Group 1 and Group 2
    • Time Frame: 6 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Male and Female, 18 to 75 years of age. 2. Negative pregnancy test required. 3. Presence of partial thickness burns to one or both hands. 4. Thermal burn etiology. Exclusion Criteria:

1. Allergy or hypersensitivity to materials in porcine-based study products or personal preference. 2. Friction, chemical, or electric burn etiology. 3. Immunosuppression. 4. Presence of a local and/or systemic infection. 5. Received prior treatment to the study site within 60 days of Screening. 6. Concurrent participation in another clinical trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Integra LifeSciences Corporation
  • Collaborator
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Blair Summitt, MD, Principal Investigator, Vanderbilt University Medical Center, Regional Burn Center
    • Wesley Thayer, MD, Principal Investigator, Vanderbilt University Medical Center, Regional Burn Center

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