Plastic Surgery Research Council
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DEVELOPMENT OF AN ELASTIC BIODEGRADABLE NANOCOMPOSITE DEVICE FOR TISSUE DISTRACTION
Presenter: Nicole Levi-Polyachenko, PhD
Co-Authors: Rosenbalm T; Wagner W; David L; Sanger C; Morykwas M; Argenta L; Wood B
Wake Forest Baptist Health

Purpose: The principle of distraction osteogenesis may be applied to cleft palate repair by remodeling the palatal plate while simultaneously initiating expansion of the soft tissues. This technique has been shown to effectively induce cleft palate closure in a canine model in a minimally invasive manner with a low relapse rate. As the development of biodegradable elastic materials continues to evolve, the potential for incorporation of these polymers in tissue distraction devices has presented a viable option for cleft palate closure. The purpose of this study was to develop a biodegradable elastomer and optimize its mechanical characteristics to facilitate palatal tissue distraction.

Methods: Synthesis of a 1,8 (poly-octanediol) citrate polymer was performed and combined with nanometer-sized hydroxyapatite (nHA). Mechanical properties and force for closure were determined in an ex vivo model. Young swine (age 2 months or 10 kilograms) underwent creation of a cleft palate with a midline osteotomy. The biodegradable device was stretched and applied under a specific tensile load using a custom distractor and the materials were secured using resorbable bone screws, after which the animals were observed on a weekly basis over a six-week period.

Results: A loading of 3% nano-hydroxyapatite was found to give the ideal mechanical properties to induce cleft closure at approximately 1mm per day of tissue movement. The necessary properties of the composite were determined to be an elastic modulus of 5 MPa or less, with a tensile strength greater than 0.2 MPa and a maximum force load of up to 20 N. No adverse effects of the material were noted.

Conclusions: The induction of cleft palate closure would serve to improve velopharyngeal competence while reducing the amount of definitive surgical intervention necessary. This study demonstrates the ability to develop a biodegradable material with specifically determined mechanical properties related to applied force and tensile strength. The development of a resorbable tissue transport device may have significant implications in facilitating cleft palate closure.


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