NCT03598023

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Partial Thickness Burn of Hand

Interventions

Type	Name	Description
DEVICE	Cytal® Burn Matrix	Cytal® Burn Matrix
DEVICE	EZ-Derm® Porcine Xenograft	EZ-Derm® Porcine Xenograft

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-07-01
• Completion: 2020-12-31
• First posted: 2018-07-26
• Last updated: 2021-04-01

Regulatory

• FDA-regulated device study