Partial-thickness BurnNCT03613870
PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
A study testing PermeaDerm and Mepilex Ag in people with Partial-thickness Burn, run by The University of Texas Medical Branch, Galveston.
Trial summary
The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden) Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Partial-thickness 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Jul 2018to 11 Jul 2019
- 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 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Superficial partial thickness burn injury due to flame burn, scald injury or contact burn that does not require excision and grafting
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
- Non-infected wound as diagnosed by the attending physician upon admission
- Treated as an outpatient or in an observational setting
Who cannot join
- Patient younger than 6 months
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other pseudo eschar-forming topical agents
- Pregnancy/lactation
About this study
Official title: A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)
Read the detailed description
In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs.
60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting.
Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy.
Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).
- Conditions
- Partial-thickness Burn
- Being tested
- PermeaDerm, Mepilex Ag
- Keywords
- PermeaDerm, Mepilex Ag, partial thickness burn wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermeaDermDevice
Wound treatment with PermeaDerm
Mepilex AgDevice
Wound treatment with Mepilex Ag
| Study group | Role | What they receive |
|---|---|---|
| PermeaDerm | Active comparator | Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely Receives: Device: PermeaDerm |
| Mepilex Ag | Active comparator | Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely Receives: Device: Mepilex Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to heal
Time until wound is complete healed in days. A wound is considered as completely healed, when either PermeaDerm detaches on its own or no more dressings need to be applied in the Mepilex group. This time point is defined when approximately 95% of the wound shows epithelialization as determined by an experienced burn surgeon.
Measured: up to 3 weeks after injury
Secondary outcomes (13)
Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)
Pain assessment using Visual Analog Scale rating Pain scores ranging from 0-10 (8 years and older) OR Wong-Baker FACES Pain Rating Scale (3-7 years old). FACES stands for faces, since this rating scale shows faces from very happy to very unhappy. It ranges also from 0-10. Higher values indicating greater pain. The 0-10 scores for each scale are equivalent.
Measured: Changes over first 30 days post injury, using regression modeling for analysis.
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.
Measured: at 1 month post injury
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.
Measured: at 6 months post injury
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Measured: at 1 month post injury
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Measured: at 6 months post injury
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Measured: at 1 month post injury
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Measured: at 6 months post injury
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Measured: at 1 month post injury
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Measured: at 6 months post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Measured: at 1 month post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Measured: at 6 months post injury
Rate of Infection
Defined as bacterial growth of >10 to power of 5 in swab. Only taken when infection suspected.
Measured: at 1 month post burn
Cost-effectiveness
Number of dressing changes required until healing versus respective product costs (costs per cm square)
Measured: at 1 month post burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start19 Jul 2018
- Primary completion1 Dec 2018
- Study completion11 Jul 2019
Why it stopped: Administratively closed prior enrollment of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-thickness BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludwik K Branski, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613870
- Sponsor's protocol ID
- 17-0315
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2018
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: data won't be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT03613870
- Acronym / sponsor ID
- 17-0315
- Conditions
- Partial-thickness Burn
- Keywords
- PermeaDerm, Mepilex Ag, partial thickness burn wounds
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administratively closed prior enrollment of participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 3 Aug 2018 (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.
The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)
Detailed description
In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs.
60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting.
Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy.
Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PermeaDerm | Active comparator | Device: PermeaDermParticipants receive PermeaDerm dressing for wound treatment until wounds have healed completely |
| Mepilex Ag | Active comparator | Device: Mepilex AgParticipants receive Mepilex Ag dressing for wound treatment until wounds have healed completely |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Superficial partial thickness burn injury due to flame burn, scald injury or contact burn that does not require excision and grafting
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
- Non-infected wound as diagnosed by the attending physician upon admission
- Treated as an outpatient or in an observational setting
Key exclusion criteria (6 listed)
- Patient younger than 6 months
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other pseudo eschar-forming topical agents
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 |
|---|---|---|
| PermeaDermWound treatment with PermeaDerm | Device | PermeaDerm |
| Mepilex AgWound treatment with Mepilex Ag | Device | Mepilex Ag |
Primary outcome
Time to heal
Time frame: up to 3 weeks after injury
Time until wound is complete healed in days. A wound is considered as completely healed, when either PermeaDerm detaches on its own or no more dressings need to be applied in the Mepilex group. This time point is defined when approximately 95% of the wound shows epithelialization as determined by an experienced burn surgeon.
13 secondary outcomes
Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)
Time frame: Changes over first 30 days post injury, using regression modeling for analysis.
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Time frame: at 1 month post injury
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Viscoelasticity
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Viscoelasticity
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Hydration
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Hydration
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Pigmentation
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Pigmentation
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Time frame: at 6 months post injury
Rate of Infection
Time frame: at 1 month post burn
Cost-effectiveness
Time frame: at 1 month post burn
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No. data won't be shared
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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.
Ludwik K Branski, MD principal investigator
The University of Texas Medical Branch, Galveston
Questions about this trial
What is this clinical trial studying?
A study testing PermeaDerm and Mepilex Ag in people with Partial-thickness Burn, run by The University of Texas Medical Branch, Galveston.
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 5 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to heal (time frame: up to 3 weeks after injury). 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 18 Jun 2023.