Por favor, use este identificador para citar o enlazar este ítem: https://hdl.handle.net/11000/33433

Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis


Vista previa

Ver/Abrir:
 s12905-019-0841-z.pdf

3,56 MB
Adobe PDF
Compartir:
Título :
Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis
Autor :
Acién, Pedro  
Nohales-Alfonso, Francisco J.
Sánchez-Ferrer, María Luisa  
Sánchez-Lozano, Miguel  
NAVARRO LILLO, VICTORIA  
Acién, Maribel
Editor :
BMC
Departamento:
Departamentos de la UMH::Ingeniería Mecánica y Energía
Fecha de publicación:
2019
URI :
https://hdl.handle.net/11000/33433
Resumen :
Background: To evaluate the feasibility and clinical outcomes of vaginoplasties using a neovaginal polylactic acid prosthesis made with 3-dimensional (3D) printing technology as an intraneovaginal mould. Methods: This was an interventionist, prospective, and multicentre clinical pilot investigation of a sanitary product (PACIENA prosthesis®) aiming to recruit and operate on 8 patients over 6 months with a follow-up period of 6 months. Only six patients with Rokitansky syndrome and one patient with Morris syndrome (7 patients in total) were operated on in two university hospitals: “La Fe”, Valencia (H1) and “Arrixaca”, Murcia (H2). Interventions: Extensive surgical dissection of a defined space between the urethra and bladder in the front and of the rectum in the back as well as insertion of the PACIENA prosthesis® covered with Interceed® were performed. After 12 days, the prosthesis was changed to the silicone-covered version for daily application. Results: In the 6 patients with Rokitansky syndrome (86%), the primary endpoint (satisfactory vaginal outcome in terms of appearance, function, and sensation without relevant additional morbidity) was achieved, although only 2 patients (28%) were sexually active at the end of 6 months of follow-up. The patient with Morris syndrome withdrew from the study after 1 month. Patients without bacterial colonization showed positive Schiller tests at 1 month, and subsequent biopsies showed adequate keratinization and epidermization. Epithelization and iodopositivity were delayed in the patients who developed inflammatory granulomas. Conclusions: Good anatomical and functional results can be achieved with the PACIENA prosthesis® for vaginoplasties without skin grafts. However, adequate patient selection and education, good surgical techniques and haemostasis, postoperative support, and prevention of bacterial colonization are important. Trial registration: This clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.
Palabras clave/Materias:
Vaginal agenesis
Vaginoplasty
Neovaginal prosthesis
Rokitansky syndrome
Área de conocimiento :
CDU: Ciencias aplicadas: Ingeniería. Tecnología
Tipo documento :
application/pdf
Derechos de acceso:
info:eu-repo/semantics/openAccess
Attribution-NonCommercial-NoDerivatives 4.0 Internacional
DOI :
https://doi.org/10.1186/s12905-019-0841-z
Aparece en las colecciones:
Artículos Ingeniería Mecánica y Energía



Creative Commons La licencia se describe como: Atribución-NonComercial-NoDerivada 4.0 Internacional.