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Ensaio clínico

Avaliação do Manifold Interno na Reconstrução de Mama Baseada em Implante

NCT: NCT05975359 · ACTIVE_NOT_RECRUITING

ID NCTNCT05975359
EstadoACTIVE_NOT_RECRUITING
Data de início2023-09-05
SponsorStanford University (OTHER)
First posted
Last updated

Resumo breve

Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.

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