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

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Integra LifeSciences

Status

Withdrawn

Conditions

Partial Thickness Burn of Hand

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03598023
CR2017-001

Details and patient eligibility

About

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 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)

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Group 1
Active Comparator group
Description:
Cytal® Burn Matrix
Treatment:
Device: Cytal® Burn Matrix
Group 2
Active Comparator group
Description:
EZ-Derm® Porcine Xenograft
Treatment:
Device: EZ-Derm® Porcine Xenograft

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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