Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations.
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.
Macchiarini
P
P
Departments of Thoracic and Vascular Surgery and Heart-Lung Transplantation, Marie-Lannelongue Hôpital, Paris-Sud University, Le Plessis Robinson, France.
Wain
J
J
Almy
S
S
Dartevelle
P
P
D000818:Animals; D015505:Chest Tubes; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D013552:Swine; D014014:Tissue Adhesives / Q000627:therapeutic use*
D014014:Tissue Adhesives