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This prospective, randomized, double-blind Phase III clinical trial with a single crossover design examines the efficacy of two experimental variables in maxillofacial prosthetics. The study involves blinded patient populations from MDACC and TSRCC, evaluating the preferred prosthesis, outcome measures, and patient-reported outcomes over an indefinite time period.
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+ Blinded patient population - Controlled, Randomized, Double-Blind, Multicenter, Prospective, Phase III Clinical Trial with Single Crossover Experimental variable (CPE) Experimental variable (CPE) Recruit patients: 67 at MDACC, 33 at TSRCC. Entry Health Q, Informed Consent 4 months + 4 months Indefinite time =======► - - C R O S S O V E R RANDOMIZE OutcomeMeasures: Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™ (Exit Q), Temp/humidity ______________________________________________________________________- Global question:Which prosthesis do you want to continue wearing? Patient wears the preferred prosthesis; follow-up by 4-month PEQ-Telephone Survey Outcome Measure: Outgoing Clinical Q, TOMCP, LASA,SF-8™ Temp/humidity Outcome Measure: Outgoing Clinical Q, TOMCP, Temp/humidity Outcome Measures: Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™ (Exit Q), Temp/humidity Visit 4 Visit 5 Visit 3 + Visit 6 4 months + 4 months Visits 1 & 2 =======► - Control variable (silicone) Indefinite time Control variable (silicone) Fabrication of 1st prosthesis by anaplastologist; ADLTQ Fabrication of 2nd prosthesis by anaplastologist; ADLTQ Q ≡ questionnaire “Multicenter Trial of CPE for Maxillofacial Prosthetics”
