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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-12-31

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.

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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)

Conditions

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Partial Thickness Burn of Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-site, randomized, prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Cytal® Burn Matrix

Group Type ACTIVE_COMPARATOR

Cytal® Burn Matrix

Intervention Type DEVICE

Cytal® Burn Matrix

Group 2

EZ-Derm® Porcine Xenograft

Group Type ACTIVE_COMPARATOR

EZ-Derm® Porcine Xenograft

Intervention Type DEVICE

EZ-Derm® Porcine Xenograft

Interventions

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Cytal® Burn Matrix

Intervention Type DEVICE

EZ-Derm® Porcine Xenograft

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No