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

Partial Thickness Burn of Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03598023
• Other study ID #: CR2017-001
• Status: Withdrawn
• Phase: N/A
• Start date: August 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Partial Thickness Burn of Hand

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Wound Healing	To Compare the time to complete wound healing between Groups 1 and 2	6 months
Secondary	Evaluation of Scar Formation	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.	6 months
Secondary	Wounds Requiring Autografting	The total number of wounds that required the use of autografting by 6 months will be compared between Groups 1 and 2.	6 months
Secondary	Wound Infections	The total number of burn wound infections between Group 1 and 2	21 days
Secondary	Rate of Healing	Measured by change in wound surface area over time, in cm2/week between Groups 1 and 2.	6 months
Secondary	Hand Function	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.	6 months
Secondary	Impact of Treatment	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.	6 months
Secondary	Compare treatment-emergent adverse event safety profile between Group 1 and Group 2	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.	6 months