OBJECTIVES/HYPOTHESIS: To determine the resorption rate and biocompatibility characteristics of novel cross-linked hydrogel ventilation tubes and varied formulations of polyester ventilation tubes in a Chinchilla model. STUDY DESIGN: Animal Study. METHODS: Three cross-linked glycosaminoglycan hydrogel ventilation tubes fabricated by cross-linking thiol-modified chondroitin sulfate or thiol-modified carboxymethylated hyaluronic acid, four different polyester ventilation tubes (poly L-lactide [PLA], 50/50 poly D,L-lactide-co-glycolide [PLGA], and silver-impregnated versions of PLA and PLGA tubes) were placed into the tympanic membranes of chinchillas. Commercially available fluoroplastic ventilation tubes were placed in the contralateral ear of each animal to serve as a control. Integrity of the tubes was assessed by weekly otoscopy. Biocompatibility was assessed by auditory brainstem response, by otoscopic and histologic examination of the tympanic membrane at the tube site. RESULTS: The hydrogel tubes had very short resorption times that expanded and enlarged the myringotomy site. PLGA and silver-coated PLGA tubes maintained their integrity in the tympanic membrane for similar durations of 18.9 ± 6.4 days and 21.0 ± 6.0 days, respectively. The silver-coated PLGA tubes had lower neutrophil and fibrosis scores than PLGA tubes. PLA tubes demonstrated equivalent findings to commercially available nonresorbable tubes with respect to otoscopic findings, auditory brainstem response thresholds, and histologic inflammatory scores. CONCLUSIONS: Resorbable polyester pressure equalization tubes demonstrate predictable resorption behavior and similar biocompatibility characteristics when compared with nonresorbable tubes. Silver modification may confer some stability to PLGA tubes. Hydrogel tubes have very short resorption times, tend to enlarge the myringotomy site, and show greater inflammatory changes.
OBJECTIVES/HYPOTHESIS: To determine the resorption rate and biocompatibility characteristics of novel cross-linked hydrogel ventilation tubes and varied formulations of polyester ventilation tubes in a Chinchilla model. STUDY DESIGN: Animal Study. METHODS: Three cross-linked glycosaminoglycan hydrogel ventilation tubes fabricated by cross-linking thiol-modified chondroitin sulfate or thiol-modified carboxymethylated hyaluronic acid, four different polyester ventilation tubes (poly L-lactide [PLA], 50/50 poly D,L-lactide-co-glycolide [PLGA], and silver-impregnated versions of PLA and PLGA tubes) were placed into the tympanic membranes of chinchillas. Commercially available fluoroplastic ventilation tubes were placed in the contralateral ear of each animal to serve as a control. Integrity of the tubes was assessed by weekly otoscopy. Biocompatibility was assessed by auditory brainstem response, by otoscopic and histologic examination of the tympanic membrane at the tube site. RESULTS: The hydrogel tubes had very short resorption times that expanded and enlarged the myringotomy site. PLGA and silver-coated PLGA tubes maintained their integrity in the tympanic membrane for similar durations of 18.9 ± 6.4 days and 21.0 ± 6.0 days, respectively. The silver-coated PLGA tubes had lower neutrophil and fibrosis scores than PLGA tubes. PLA tubes demonstrated equivalent findings to commercially available nonresorbable tubes with respect to otoscopic findings, auditory brainstem response thresholds, and histologic inflammatory scores. CONCLUSIONS: Resorbable polyester pressure equalization tubes demonstrate predictable resorption behavior and similar biocompatibility characteristics when compared with nonresorbable tubes. Silver modification may confer some stability to PLGA tubes. Hydrogel tubes have very short resorption times, tend to enlarge the myringotomy site, and show greater inflammatory changes.
Authors: Sarah A Bradner; Deepa Galaiya; Nikhila Raol; David L Kaplan; Chistopher J Hartnick Journal: Adv Healthc Mater Date: 2019-01-09 Impact factor: 9.933