Thermal BurnNCT05084183
Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®
A study testing PermeaDerm® and Mepilex Ag in people with Thermal Burn, run by Stedical Scientific, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Thermal Burn
- What is being tested?
- PermeaDerm® and Mepilex Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants will be included if all the following criteria are met.
- Able to give informed consent and undergo treatment < 72 hours of injury (consent may be given by LAR as necessary);
- Any adult or pediatric patient < 75 years of age;
- 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;
- 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;
- 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;
- Demonstrates the ability and willingness to follow the requirements of the protocol.
Who cannot join
- Participants will be excluded if s/he meet any of the following criteria.
- Pregnant or breastfeeding;
- Target burn ≥ 20% TBSA;
- Electrical burns, chemical burns, frostbite;
- Treatment with silver sulfadiazine prior to presentation;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis
Sacramento, California, 95817
David Greenhalgh, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thermal Burn
- Being tested
- PermeaDerm®, Mepilex Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermeaDerm®Device
Wound Management Device
Mepilex AgDevice
Wound Dressing
| Study group | Role | What they receive |
|---|---|---|
| PermeaDerm® | Experimental | N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use Receives: Device: PermeaDerm® |
| Mepilex Ag® | Active comparator | Participants will receive application of Mepilex Ag® as outlined in Directions for Use. Receives: Device: Mepilex Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reepithelialization
Time to 100 percent- primary wound
Measured: 14 days
Alternate therapy
Time to conversion to alternate therapy- primary wound
Measured: 14 days
Secondary outcomes (7)
Re-epithelialization
Percent reepithelialization primary and secondary Wounds
Measured: 14 days
Alternate therapy
Time to conversion to alternate therapy- secondary wounds
Measured: up to 12 Months
Adverse Events
Occurrence, duration, severity, seriousness, expectedness, and relationship of adverse events
Measured: 21 days
Severity of pain
Wong-Backer Faces pain rating scale and in adults as measured by the Numerical Rating Scale (0-10);
Measured: Up to 12 Months
Scar characteristics
Patient and Observer Scar Assessment Scale (POSAS)
Measured: 6 and 12 months
Satisfaction with treatment
Brisbane Burn Scar Impact Profile (BBSIP)
Measured: 6 and 12 months
Dressing Changes Required
Number
Measured: Up to 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start2 Feb 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, single-blinded, adaptive, controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stedical Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Greenhalgh, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084183
- Sponsor's protocol ID
- ST-2021-B001
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05084183
- Acronym / sponsor ID
- ST-2021-B001
- Conditions
- Thermal Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Stedical Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-blinded, adaptive, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| PermeaDerm® | Experimental | Device: PermeaDerm®N=34 Participants will receive application of PermeaDerm® as outlined in Directions for Use |
| Mepilex Ag® | Active comparator | Device: Mepilex AgParticipants will receive application of Mepilex Ag® as outlined in Directions for Use. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Participants will be included if all the following criteria are met.
- Able to give informed consent and undergo treatment < 72 hours of injury (consent may be given by LAR as necessary);
- Any adult or pediatric patient < 75 years of age;
- 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;
- 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;
Key exclusion criteria (6 listed)
- Participants will be excluded if s/he meet any of the following criteria.
- Pregnant or breastfeeding;
- Target burn ≥ 20% TBSA;
- Electrical burns, chemical burns, frostbite;
- Treatment with silver sulfadiazine prior to presentation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PermeaDerm®Wound Management Device | Device | PermeaDerm® |
| Mepilex AgWound Dressing | Device | Mepilex Ag® |
Primary outcome
Reepithelialization
Time frame: 14 days
Time to 100 percent- primary wound
Alternate therapy
Time frame: 14 days
Time to conversion to alternate therapy- primary wound
7 secondary outcomes
Re-epithelialization
Time frame: 14 days
Alternate therapy
Time frame: up to 12 Months
Adverse Events
Time frame: 21 days
Severity of pain
Time frame: Up to 12 Months
Scar characteristics
Time frame: 6 and 12 months
Satisfaction with treatment
Time frame: 6 and 12 months
Dressing Changes Required
Time frame: Up to 21 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Greenhalgh, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PermeaDerm® and Mepilex Ag in people with Thermal Burn, run by Stedical Scientific, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miao Yu, Ph.D (1-858-753-9530, miao.yu@stedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reepithelialization (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.