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Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®

NCT05084183 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-06-27

No results posted yet for this study

Summary

A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.

Conditions

  • Thermal Burn

Interventions

DEVICE

PermeaDerm®

Wound Management Device

DEVICE

Mepilex Ag

Wound Dressing

Sponsors & Collaborators

  • Stedical Scientific, Inc.

    lead INDUSTRY

Principal Investigators

  • David Greenhalgh, M.D. · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2022-11-30
Completion
2023-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084183 on ClinicalTrials.gov