Clinical trial NCT03598023: A Study to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
Official title: A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Partial Thickness Burn of Hand
Keywords: ACell
Hand
Burn
ACell Cytal Burn Matrix®
Extracellular Matrix
Urinary Bladder Matrix
Wound
Partial-Thickness
Burn Management
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
First posted: 2018-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-site, randomized, prospective study
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Complete Wound Healing
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Scar Formation
timeFrame: 6 months
measure: Wounds Requiring Autografting
timeFrame: 6 months
measure: Wound Infections
timeFrame: 21 days
measure: Rate of Healing
timeFrame: 6 months
measure: Hand Function
timeFrame: 6 months
measure: Impact of Treatment
timeFrame: 6 months
measure: Compare treatment-emergent adverse event safety profile between Group 1 and Group 2
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center, Regional Burn Center
name: Blair Summitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center, Regional Burn Center
name: Wesley Thayer, MD
role: PRINCIPAL_INVESTIGATOR
References: