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

June 21, 2022 updated by: Stedical Scientific, Inc.

An Adaptive, Randomized, Controlled Trial Evaluating the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag® Used as Standard of Care in the Treatment of Adult and Pediatric Partial Thickness Burns.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 from the clinical practices of the site Principal Investigators.

Participants and/or the Legally Authorized Representative (LAR) as appropriate will be fully informed regarding the conduct of the clinical trial including all potential risks and benefits.

All Participants must be consented, randomized (1:1) and treated within 72 hours of injury.

It is permissible for a Study Participant to be enrolled if they have more than one burn wound.

If more than one partial thickness burn is treated, the Investigator must indicate prior to randomization which wound is to be considered for primary analysis. This wound will be called the Primary Wound and is to be evaluated by a Blinded Assessor.

Additional partial thickness wounds must be treated with the same product to which the Study Participant was randomized and will be included in secondary analysis. These wounds are to be described as Secondary Wounds and are to be evaluated by the Unblinded Assessor.

Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
          • David Greenhalgh, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants will be included if all the following criteria are met.

  1. Able to give informed consent and undergo treatment < 72 hours of injury (consent may be given by LAR as necessary);
  2. Any adult or pediatric patient < 75 years of age;
  3. Target burn to be at least one discrete partial thickness (second degree) thermal burns <20% total body surface area (TBSA) on anybody surface except the face;
  4. Characteristics of treated wound (s) must be superficial to deep partial thickness wounds such that application of both PermeaDerm and Mepilex Ag is medically appropriate;
  5. Agrees to abstain from the use of any other wound covering device for the duration of the study unless determined by the individual site Principal Investigator to be medically necessary;
  6. Demonstrates the ability and willingness to follow the requirements of the protocol.

Exclusion Criteria:

Participants will be excluded if s/he meet any of the following criteria.

  1. Pregnant or breastfeeding;
  2. Target burn ≥ 20% TBSA;
  3. Electrical burns, chemical burns, frostbite;
  4. Treatment with silver sulfadiazine prior to presentation;
  5. Has comorbidities and/or medications and/or health status that (at the discretion of the individual site Principal Investigator) could result in poor wound healing (some examples may include admission to intensive care unit, inhalation, or other significant burn associated conditions, uncontrolled and/or significant diabetes, peripheral vascular disease, active malignancy, autoimmune disease, smoking, drug abuse, renal failure, steroid usage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PermeaDerm®
N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use
Device: PermeaDerm®
Wound Management Device
Active Comparator: Mepilex Ag®
Participants will receive application of Mepilex Ag® as outlined in Directions for Use.
Device: Mepilex Ag
Wound Dressing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reepithelialization
Time Frame: 14 days
Time to 100 percent- primary wound
14 days
Alternate therapy
Time Frame: 14 days
Time to conversion to alternate therapy- primary wound
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Re-epithelialization
Time Frame: 14 days
Percent reepithelialization primary and secondary Wounds
14 days
Alternate therapy
Time Frame: up to 12 Months
Time to conversion to alternate therapy- secondary wounds
up to 12 Months
Adverse Events
Time Frame: 21 days
Occurrence, duration, severity, seriousness, expectedness, and relationship of adverse events
21 days
Severity of pain
Time Frame: Up to 12 Months
Wong-Backer Faces pain rating scale and in adults as measured by the Numerical Rating Scale (0-10);
Up to 12 Months
Scar characteristics
Time Frame: 6 and 12 months
Patient and Observer Scar Assessment Scale (POSAS)
6 and 12 months
Satisfaction with treatment
Time Frame: 6 and 12 months
Brisbane Burn Scar Impact Profile (BBSIP)
6 and 12 months
Dressing Changes Required
Time Frame: Up to 21 Days
Number
Up to 21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stedical Scientific, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Greenhalgh, M.D., University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST-2021-B001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thermal Burn

Clinical Trials on PermeaDerm®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings