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Open Access 01-12-2016 | Research article

Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks

Authors: Bernard J. Park, John M. Snider, Nathan R. Bates, Stephen D. Cassivi, G. Kimble Jett, Joshua R. Sonett, Eric M. Toloza

Published in: Journal of Cardiothoracic Surgery | Issue 1/2016

Abstract

Background

A biodegradable polymeric sealant has been previously shown to reduce postoperative air leaks after open pulmonary resection. The aim of this study was to evaluate safety and efficacy during minimally invasive pulmonary resection.

Methods

In a multicenter prospective single-arm trial, 112 patients with a median age of 69 years (range 34–87 years) were treated with sealant for at least one intraoperative air leak after standard methods of repair (sutures, staples or cautery) following minimally invasive pulmonary resection (Video-Assisted Thoracic Surgery (VATS) or Robotic-Assisted). Patients were followed in hospital and 1 month after surgery for procedure-related and device-related complications and presence of air leak.

Results

Forty patients had VATS and 72 patients had Robotic-Assisted procedures with the majority (80/112, 71%) undergoing anatomic resection (61 lobectomy, 13 segmentectomy, 6 bilobectomy). There were no device-related adverse events. The overall morbidity rate was 41% (46/112), with major complications occurring in 16.1% (18/112). In-hospital mortality and 30-day mortality were 1.9% (2/103). The majority of intraoperative air leaks (107/133, 81%) were sealed after sealant application, and an additional 16% (21/133) were considered reduced. Forty-nine percent of patients (55/112) were free of air leak throughout the entire postoperative study period. Median chest tube duration was 2 days (range 1 – 46 days), and median length of hospitalization was 3 days (range 1 – 20 days).

Conclusions

This study demonstrated that use of a biodegradable polymer for closure of intraoperative air leaks as an adjunct to standard methods is safe and effective following minimally invasive pulmonary resection.

Trial registration

ClinicalTrials.gov: NCT01867658. Registered 3 May 2013.

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Title: Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks
Authors: Bernard J. Park
John M. Snider
Nathan R. Bates
Stephen D. Cassivi
G. Kimble Jett
Joshua R. Sonett
Eric M. Toloza
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Journal of Cardiothoracic Surgery / Issue 1/2016
Electronic ISSN: 1749-8090
DOI: https://doi.org/10.1186/s13019-016-0563-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks

Abstract

Background

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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