{"id":"W4393390558","doi":"10.1186/s13063-024-08070-4","title":"A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial","year":2024,"lang":"en","type":"article","venue":"Trials","topic":"Wound Healing and Treatments","field":"Medicine","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Royan Institute; Royan Institute for Stem Cell Biology and Technology","keywords":"Medicine; Transplantation; Second-Degree Burn; Surgery; Randomized controlled trial; Total body surface area; Burn injury; Burn center; Clinical trial; Single Center; Debridement (dental); Keratinocyte; Wound healing; Burn wound; Poison control; Emergency medicine; Internal medicine","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01742686,0.004574531,0.007720498,0.001217039,0.001692942,0.002016945,0.002381178,0.005104112,0.007410331],"category_scores_gemma":[0.00943203,0.001993974,0.002851025,0.001057972,0.004589878,0.002956155,0.001107057,0.004852658,0.002118863],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001269732,"about_ca_system_score_gemma":0.004911473,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004492852,"about_ca_topic_score_gemma":0.0008136964,"domain_scores_codex":[0.990088,0.006382623,0.0006438507,0.00123704,0.0008112036,0.0008372602],"domain_scores_gemma":[0.9929203,0.001737836,0.001255411,0.001165477,0.0008819116,0.002039032],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9574787,0.0338218,0.0007473028,0.0005574956,0.0004272985,0.00003455055,0.00007090022,0.0002465573,0.002229831,0.0001462036,0.0002502158,0.003989032],"study_design_scores_gemma":[0.8600996,0.1381273,0.0004676105,0.00002261068,0.0001724174,0.00001425865,0.00001739193,0.0002161094,0.000310633,0.0001428882,0.0003962228,0.00001284321],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"protocol","genre_scores_codex":[0.7460003,0.003422181,0.005383422,0.001424951,0.002227934,0.2369324,0.001690383,0.0002370377,0.002681386],"genre_scores_gemma":[0.6845013,0.002189206,0.01703675,0.004473713,0.002506043,0.2829073,0.001684774,0.00006335826,0.004637518],"genre_candidate":"protocol","genre_consensus":null,"teacher_disagreement_score":0.01742686,"threshold_uncertainty_score":0.09216315,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3472368239828378,"score_gpt":0.4769932773209338,"score_spread":0.129756453338096,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}