title: Repairing Fetal Membranes with a Self-adhesive Ultrathin Polymeric Film: Evaluation in Mid-gestational Rabbit Model.
abstract: Preterm premature rupture of membranes causes 40% of all preterm births, affecting 150000 women each year in the United States. Prenatal diagnostic procedures and surgical interventions increase incidence of adverse events, leading to iatrogenic membrane rupture after a fetoscopic procedure in 45% of cases. We propose an ultrathin, self-adherent, poly-L-lactic acid patch ("nanofilm") as a reparative wound closure after endoscopic/fetoscopic procedures. These nanofilms are compatible with application in wet conditions and with minimally invasive instrumentation. Ex vivo studies to evaluate the nanofilm were conducted using human chorion-amnion (CA) membranes. A custom-built inflation device was used for mechanical characterization of CA membranes and for assessment of nanofilm adhesion and sealing of membrane defects up to 3 mm in size. These ex vivo tests demonstrated the ability of the nanofilm to seal human CA defects ranging in size from 1 to 3 mm in diameter. In vivo survival studies were conducted in 25 mid-gestational rabbits, defects were created by perforating the uterus and the CA membranes and subsequently using the nanofilm to seal these wounds. These in vivo studies confirmed the successful sealing of defects smaller than 3 mm observed ex vivo. Histological analysis of whole harvested uteri 7 days after surgery showed intact uterine walls in 59% of the nanofilm repaired fetuses, along with increased uterine size and intrauterine development in 63% of the cases. In summary, we have developed an ultrathin, self-adhesive nanofilm for repair of uterine membrane defects.
authors.affiliation: Department of Biomedical Engineering, Vanderbilt University, 5824 Stevenson Center, Nashville, TN, 37235-1592, USA, virginia.pensabene@vanderbilt.edu.
authors.forename: Virginia
authors.initials: V
authors.lastname: Pensabene
authors.forename: Premal P
authors.initials: PP
authors.lastname: Patel
authors.forename: Phillip
authors.initials: P
authors.lastname: Williams
authors.forename: Trisha L
authors.initials: TL
authors.lastname: Cooper
authors.forename: Kellye C
authors.initials: KC
authors.lastname: Kirkbride
authors.forename: Todd D
authors.initials: TD
authors.lastname: Giorgio
authors.forename: Noel B
authors.initials: NB
authors.lastname: Tulipan
mesh_terms: D000818:Animals; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000601:surgery*; D006801:Humans; D019344:Lactic Acid / Q000737:chemistry / Q000494:pharmacology; D008567:Membranes, Artificial; D011091:Polyesters; D011108:Polymers / Q000737:chemistry / Q000494:pharmacology; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011817:Rabbits; D014014:Tissue Adhesives / Q000737:chemistry / Q000494:pharmacology
chemical_list: D008567:Membranes, Artificial; D011091:Polyesters; D011108:Polymers; D014014:Tissue Adhesives; D019344:Lactic Acid; C033616:poly(lactide)