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J Thorac Cardiovasc Surg 1999;117:751-758
© 1999 Mosby, Inc.


GENERAL THORACIC SURGERY

EXPERIMENTAL AND CLINICAL EVALUATION OF A NEW SYNTHETIC, ABSORBABLE SEALANT TO REDUCE AIR LEAKS IN THORACIC OPERATIONS

Paolo Macchiarini, MD, PhDa, John Wain, MDb, Susan Almy, MSc, Philippe Dartevelle, MDa

From the Departments of Thoracic and Vascular Surgery and Heart-Lung Transplantation, Marie-Lannelongue Hôpital, Paris-Sud University, Le Plessis Robinson, Francea; Thoracic Surgery, Harvard Medical School, Massachusetts General Hospital, Boston, Massb; and Statistics Unlimited, Inc, Westford, Mass.c

Received for publication July 24, 1998. Revisions requested Oct 30, 1998. Revisions received Nov 23, 1998. Accepted for publication Nov 23, 1998. Address for reprints: Paolo Macchiarini, MD, PhD, Department of Thoracic and Vascular Surgery, Heidehaus Hospital (Hannover Medical School), 70, Leineufer, D-30419, Hannover, Germany.

Background: Air leaks after pulmonary resections may contribute to increased patient morbidity, delayed removal of chest drainage tubes, and prolonged hospitalization. Objective: The purpose of this study was to investigate the effects of a new synthetic, absorbable sealant on the healing of healthy bronchial and lung tissues (experimental study) and its safety and efficacy to stop air leaks after lung resection (clinical study).
Methods: Fifteen large white pigs underwent a left upper lobectomy. All parenchymal surgical sites were sealed; the bronchial stump was either stapled, sealed, or both (n = 5 each). In the clinical study, 26 consecutive patients were prospectively randomized, intraoperatively, to standard closure of parenchymal surgical sites with (n = 15) or without (n = 11) the sealant.
Results: In the experimental study, no postoperative air leaks occurred, with intact bronchial closures and normal tissues at death. In the clinical study, 100% of intraoperative leaks were sealed versus 18% of control patients (P = .001). Although 77% (n = 10) of treated patients remained leak-free from the end of the operation to chest tube removal versus 9% (n = 1) of control patients (P = .001), there was no statistical difference in the duration of postoperative chest tube time, hospital stay, or cost. There were no acute or late undesirable side-effects related to the sealant application.
Conclusions: The surgical adhesive investigated here demonstrated a compelling safety profile and significant clinical efficacy to stop air leaks after lung resections.




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