15
Participants
Start Date
April 17, 2024
Primary Completion Date
April 17, 2028
Study Completion Date
December 17, 2028
implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).
cleft palate repair surgery, all patients in the study will receive the standard treatment (uranostaphyllorrhaphy), with the only difference that patients assigned to the experimental study group will additionally have BIOCLEFT tissue obtained through tissue engineering grafted onto them. the lateral area of the palatine bone exposed when mobilizing the flaps. For the implant, the BIOCLEFT fabric will be placed in the area of exposed bone, sized to the size of the defect and sutured using uncoated, monofilament long-term absorbable synthetic suture.
RECRUITING
University Hospital Virgen de las Nieves, Granada
Andalusian Network for Design and Translation of Advanced Therapies
OTHER
Elisa María Cubiles Montero de Espinosa
OTHER