Please use this identifier to cite or link to this item: https://hdl.handle.net/11000/33433
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dc.contributor.authorAcién, Pedro-
dc.contributor.authorNohales-Alfonso, Francisco J.-
dc.contributor.authorSánchez-Ferrer, María Luisa-
dc.contributor.authorSánchez-Lozano, Miguel-
dc.contributor.authorNAVARRO LILLO, VICTORIA-
dc.contributor.authorAcién, Maribel-
dc.contributor.otherDepartamentos de la UMH::Ingeniería Mecánica y Energíaes_ES
dc.date.accessioned2024-10-07T08:30:50Z-
dc.date.available2024-10-07T08:30:50Z-
dc.date.created2019-
dc.identifier.citationBMC Women's Health (2019) 19:144es_ES
dc.identifier.issn1472-6874-
dc.identifier.urihttps://hdl.handle.net/11000/33433-
dc.description.abstractBackground: 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.es_ES
dc.formatapplication/pdfes_ES
dc.format.extent10es_ES
dc.language.isoenges_ES
dc.publisherBMCes_ES
dc.rightsinfo:eu-repo/semantics/openAccesses_ES
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectVaginal agenesises_ES
dc.subjectVaginoplastyes_ES
dc.subjectNeovaginal prosthesises_ES
dc.subjectRokitansky syndromees_ES
dc.subject.otherCDU::6 - Ciencias aplicadas::62 - Ingeniería. Tecnologíaes_ES
dc.titleClinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesises_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.relation.publisherversionhttps://doi.org/10.1186/s12905-019-0841-zes_ES
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