Burn WoundNCT02982096
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
A study testing Cellutome Device in people with Burn Wound, run by Lehigh Valley Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Wound
- What is being tested?
- Cellutome Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2016to 1 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study.
- Age ≥18 years old.
- Patients with a total body surface area (TBSA) burn > 1% outside of the face, neck, feet or genitalia, where at least 2 areas are greater in size than 5x5cm2 or at least one area that is greater than 10cm2
Who cannot join
- Pregnant.
- Age < 18 years old.
- Proposed study area on face, neck, genitalia, or feet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
About this study
Official title: Randomized Controlled Pilot Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds
The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings).
Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.
Read the detailed description
Hypothesis:
The use of epidermal blister grafting by the CellutomeTM device in the treatment of superficial and mid-dermal burn wounds will demonstrate a difference in time to healing compared to burn wounds treated with standard acellular technique.
Primary objective:
Determine if the use of the CellutomeTM device will demonstrate a difference in healing time compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months post treatment.
Secondary objectives:
- Determine if donor sites have any visible scarring with the use of the CellutomeTM.
- Determine acute outcomes of therapy such as time to healing as assessed by ≥90% epithelialization.
- Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation).
- Conditions
- Burn Wound
- Being tested
- Cellutome Device, Standard of Care
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellutome DeviceDevice
Use of FDA approved Cellutome treatment on burn wounds
Standard of CareOther
Acellular burn wound management
| Study group | Role | What they receive |
|---|---|---|
| Cellutome treatment | Active comparator | Cellutome Device: Use of Cellutome on burn wounds Receives: Device: Cellutome Device |
| Standard of Care | Other | Standard of Care: Acellular wound management Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Measured: 12 months
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
Measured: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Visual assessment of Erythema of the donor site as compared to healthy skin
Measured: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.
Measured: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Measured: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Thickness of donor site (measured by ultrasound) compared to healthy skin
Measured: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
Measured: 12 Months
Secondary outcomes (9)
Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline
Measured: 12 months
Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
Measured: 12 months
Comparison of chronic outcomes of therapy 12 months post baseline
Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Visual assessment of Erythema of the donor site as compared to healthy skin
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Elasticity of the donor site (measured with cutometer) compared to healthy skin.
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Thickness (measured with ultrasound) compared to healthy skin
Measured: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Sensation (measured by Semmes-Weinstein) compared to healthy skin
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start23 Aug 2016
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundStudies 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigrid Blome-Eberwein, MD, Principal investigator, Lehigh Valley Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982096
- Sponsor's protocol ID
- PRO00003893
- Status last verified
- Sep 2021
- First submitted
- 7 Nov 2016
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds
- ClinicalTrials.gov ID
- NCT02982096
- Acronym / sponsor ID
- PRO00003893
- Conditions
- Burn Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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 determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings).
Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.
Detailed description
Hypothesis:
The use of epidermal blister grafting by the CellutomeTM device in the treatment of superficial and mid-dermal burn wounds will demonstrate a difference in time to healing compared to burn wounds treated with standard acellular technique.
Primary objective:
Determine if the use of the CellutomeTM device will demonstrate a difference in healing time compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months post treatment.
Secondary objectives:
- Determine if donor sites have any visible scarring with the use of the CellutomeTM.
- Determine acute outcomes of therapy such as time to healing as assessed by ≥90% epithelialization.
- Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellutome treatment | Active comparator | Device: Cellutome DeviceCellutome Device: Use of Cellutome on burn wounds |
| Standard of Care | Other | Other: Standard of CareStandard of Care: Acellular wound management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study.
- Age ≥18 years old.
- Patients with a total body surface area (TBSA) burn > 1% outside of the face, neck, feet or genitalia, where at least 2 areas are greater in size than 5x5cm2 or at least one area that is greater than 10cm2
Key exclusion criteria (3 listed)
- Pregnant.
- Age < 18 years old.
- Proposed study area on face, neck, genitalia, or feet.
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 |
|---|---|---|
| Cellutome DeviceUse of FDA approved Cellutome treatment on burn wounds | Device | Cellutome treatment |
| Standard of CareAcellular burn wound management | Other | Standard of Care |
Primary outcome
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 months
Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 Months
Assessed by Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 Months
Visual assessment of Erythema of the donor site as compared to healthy skin
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 Months
Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.
Healing time comparison of the donor site wound at 12 months post baseline
Time frame: 12 Months
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 Months
Thickness of donor site (measured by ultrasound) compared to healthy skin
Healing time comparison of the donor site wound at 12 months post baseline.
Time frame: 12 Months
Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
9 secondary outcomes
Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline
Time frame: 12 months
Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
Time frame: 12 months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- 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.
Sigrid Blome-Eberwein, MD principal investigator
Lehigh Valley Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellutome Device in people with Burn Wound, run by Lehigh Valley Hospital 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Healing time comparison of the donor site wound at 12 months post baseline. (time frame: 12 months). The study lists 7 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 10 Apr 2023.