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NCT02982096

Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique

Completed NA Last updated 10 April 2023
What this trial tests

NA trial testing Cellutome Device in Burn Wound in 9 participants. Completed in 1 December 2022.

Timeline
23 August 2016
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorLehigh Valley Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment9
Start date23 August 2016
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Lehigh Valley Hospital

Who can join

18 and older, any sex, with Burn Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advancements in Regenerative Strategies Through the Continuum of Burn Care.
    Stone Ii R, Natesan S, Kowalczewski CJ, Mangum LH, et al · · 2018 · cited 73× · PMID 30038569 · DOI 10.3389/fphar.2018.00672

Verify or expand the search:

Other recruiting trials for Burn Wound

Currently open trials in the same condition.

Other Lehigh Valley Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02982096.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing