Universitat Politècnica de Catalunya. Departament d'Enginyeria de Sistemes, Automàtica i Informàtica Industrial, Universitat Politècnica de Catalunya. GRINS - Grup de Recerca en Robòtica Intel·ligent i Sistemes, Micheletti, Talita, Eixarch Roca, Elisenda, Febas Bosomba, Germán, Berdún Martín, Sergio, Parra Hernández, Johanna, Hernansanz Prats, Alberto, Borrós Gómez, Salvador, Gratacós Solsona, Eduard, Universitat Politècnica de Catalunya. Departament d'Enginyeria de Sistemes, Automàtica i Informàtica Industrial, Universitat Politècnica de Catalunya. GRINS - Grup de Recerca en Robòtica Intel·ligent i Sistemes, Micheletti, Talita, Eixarch Roca, Elisenda, Febas Bosomba, Germán, Berdún Martín, Sergio, Parra Hernández, Johanna, Hernansanz Prats, Alberto, Borrós Gómez, Salvador, and Gratacós Solsona, Eduard
BACKGROUND: Preterm prelabor rupture of membranes is the most frequent complication of fetoscopic surgery. Strategies to seal the membrane defect created by fetoscopy have been attempted with little success. We previously developed an integrated semirigid bioadhesive patch composed of silicone and hydroxypropyl methylcellulose that achieved ex vivo sealing of membrane defects. OBJECTIVE: To evaluate the feasibility of the insertion of our integrated semirigid bioadhesive patches using a fetoscopic technique and to test the adhesion in ex vivo human membranes and in an in vivo ovine model. STUDY DESIGN: An experimental study involving 2 experiments: (1) ex vivo—human fetal membranes were mounted in a custom-designed model with saline solution simulating intraamniotic pressure. The insertion of 2 different bioadhesive patches made of silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose was performed through a 12-Fr cannula mimicking fetoscopic surgery technique. The experiment was repeated 10 times with membranes from different donors. Measures included insertion time, successful insertion, and adhesion at 5 minutes; (2) in vivo—16 patches of silicone-hydroxypropyl methylcellulose were inserted by fetoscopy in the amniotic cavity of pregnant sheep (4 bioadhesives per animal, in 4 ewes). Measures included successful insertion, adhesion at 5 minutes, and adhesion at the end of surgery. RESULTS: In the ex vivo insertion study, there was no difference in the insertion time between silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose patches (P=.49). Insertion was successful in all cases, but complete adhesion at 5 minutes was superior for silicone-hydroxypropyl methylcellulose (P=.02). In the in vivo study, insertion of silicone-hydroxypropyl methylcellulose by fetoscopy was feasible and successful in all cases, and no complications were reported. Adhesion persisted at 5 minutes and at the, This project has been funded by the Cellex Foundation and the Erasmus+ Programme of the European Union (Framework Agreement number: 2013-0040). This publication reflects only the authors’ views, and the Commission cannot be held responsible for any use that may be made of the information contained therein. T.M. was supported by a predoctoral grant from Erasmus Mundus FetalMed-PhD. E.E. has received funding from the Departament de Salut under grant number SLT008/18/00156., Peer Reviewed, Postprint (published version)