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

Not Applicable

Withdrawn

• Conditions: Partial Thickness Burn of Hand
• Interventions: Device: EZ-Derm® Porcine Xenograft; Device: Cytal® Burn Matrix

• Registration Number: NCT03598023
• Lead Sponsor: Integra LifeSciences Corporation

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)

Study Timeline

• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-08
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	EZ-Derm® Porcine Xenograft	EZ-Derm® Porcine Xenograft
Group 1	Cytal® Burn Matrix	Cytal® Burn Matrix

Primary Outcome Measures

Name	Time	Method
Time to Complete Wound Healing	6 months	To Compare the time to complete wound healing between Groups 1 and 2

Secondary Outcome Measures

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