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NCT02982096 · ClinicalTrials.gov registry record · NA
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
A NA study of Burn Wound, sponsored by Lehigh Valley Hospital.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT02982096: Completed NA study of Burn Wound, sponsored by Lehigh Valley Hospital.
NCT02982096 is a NA study of Burn Wound that has completed, run by Lehigh Valley Hospital. The registered enrollment target is 9 participants, below the 83-participant average among 3 other Burn Wound trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02982096, a NA study of Burn Wound, has completed, sponsored by Lehigh Valley Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study 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). 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.
Primary Outcome
Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Conditions Studied
Interventions
- OTHER Standard of Care
- DEVICE Cellutome Device
Study Locations (1)
Pennsylvania
- Lehigh Valley Health Network - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-08-23 |
| Est. Completion | 2022-12-01 |
| Phase | NA |
What the finished NCT02982096 record still lists
NCT02982096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 83-participant average among 3 other Burn Wound trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Burn Wound appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT02982096 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02982096 about?
NCT02982096 is a clinical study titled "Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique". 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% epithelializ...
What is the current status of trial NCT02982096?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2016-08-23. Estimated completion is 2022-12-01.
What conditions does trial NCT02982096 study?
This clinical trial studies the following conditions: Burn Wound.
What interventions are being tested in trial NCT02982096?
The interventions under investigation include: Standard of Care (OTHER), Cellutome Device (DEVICE).
Who is sponsoring clinical trial NCT02982096?
This trial is sponsored by Lehigh Valley Hospital, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02982096 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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