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Record W4416583843 · doi:10.2196/74159

Utility of RECELL for Traumatic Skin Defects: Protocol for a Prospective, Single-Arm Pilot Study

2025· article· en· W4416583843 on OpenAlexvenueaboutno aff
Naoki Maegawa, Hironobu Konishi, Keisuke Masuda, Akinori Okuda, Hideki Asai, Keita Miyazaki, Yasuyuki Kawai, Hidetada Fukushima

Bibliographic record

VenueJMIR Research Protocols · 2025
Typearticle
Languageen
FieldMedicine
TopicSurgical Sutures and Adhesives
Canadian institutionsnot available
Fundersnot available
KeywordsProtocol (science)Adverse effectClinical trialWound closureMEDLINE

Abstract

fetched live from OpenAlex

Background: Skin grafting is currently the gold standard for managing traumatic skin defects. However, split-thickness skin grafting, the most common technique, is challenging because it yields a limited amount of skin and creates a new wound at the healthy donor site. RECELL (Avita Medical), a noncultured skin cell suspension technique, yields healing outcomes with comparable duration and quality to skin grafting for burn trauma. Although RECELL is widely used for burn trauma, its use for severe traumatic skin defects is not yet prevalent in Japan. Objective: This study aims to evaluate the utility of the RECELL skin reconstruction technique in trauma cases involving significant skin defects. Specifically, the primary aim is to validate the efficacy of the RECELL skin reconstruction technique when combined with split-thickness mesh grafting in patients with significant posttraumatic skin defects, with a particular focus on wound closure and scar quality. Methods: This prospective, single-center, open-label pilot study will enroll patients aged 16 years and older with traumatic limb skin defects ≥160 cm² and sufficient dermal-like tissue. Participants will undergo RECELL-assisted autologous skin grafting with mesh grafts under general anesthesia. Wound healing, scarring (Vancouver Scar Scale), and pain (visual analog scale) will be assessed up to 24 weeks postoperatively. The primary end point is ≥95% reepithelialization at postoperative day 14. Descriptive statistical analyses will be performed to evaluate outcomes and inform future randomized trials. Results: Patient recruitment began in April 2024 and is currently ongoing in our hospital. As of April 10, 2025, 10 patients had been screened, of whom 4 were enrolled. No adverse events or protocol deviations have been noted. Conclusions: This study aims to validate the utility of RECELL for skin defects resulting from trauma by assessing wound closure and scar formation, including adverse events, delayed healing, infection, and durability.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.002
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.436
Threshold uncertainty score0.683

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.452
GPT teacher head0.592
Teacher spread0.139 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2025
Admission routes2
Has abstractyes

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