A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal™): report of a three-center phase II clinical trial

European Journal of Cardio-thoracic Surgery

Volumn 29, Issue 6, 2006, Pages 880-885

  Thomas, Pascal ^a   Massard, Gilbert ^b   Porte, Henri ^c   Doddoli, Christophe ^a   Ducrocq, Xavier ^b   Conti, Massimo ^c  

^a AP HM   (France)

^b UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^c LILLE UNIVERSITY HOSPITAL   (France)

Author keywords

Lung surgery; New technology

Indexed keywords

ANTIBIOTIC AGENT; CALCIUM ALGINATE;

ABSCESS; ADULT; AGED; ARTICLE; BIODEGRADABLE IMPLANT; BIOMEDICAL TECHNOLOGY ASSESSMENT; BRONCHUS FISTULA; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EMPHYSEMA; EMPYEMA; FEASIBILITY STUDY; FEMALE; FEVER; FOLLOW UP; HEMOPTYSIS; HEMOSTASIS; HOSPITALIZATION; HUMAN; LUNG ASPERGILLOSIS; LUNG BIOPSY; LUNG LOBECTOMY; LUNG PRESSURE; LUNG RESECTION; MAJOR CLINICAL STUDY; MALE; METALLOPTYSIS; MULTICENTER STUDY; PNEUMONIA; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RECURRENT INFECTION; RESPIRATORY AIRFLOW; SAFETY; STAPLER; SURGICAL STAPLING; THORAX DRAINAGE;

ABSORBABLE IMPLANTS; ADULT; AGED; AGED, 80 AND OVER; ALGINATES; FEMALE; FOLLOW-UP STUDIES; GLUCURONIC ACID; HEMOSTASIS, SURGICAL; HEXURONIC ACIDS; HUMANS; LENGTH OF STAY; MALE; MIDDLE AGED; PNEUMONECTOMY; PNEUMOTHORAX; POSTOPERATIVE CARE; PROSPECTIVE STUDIES; SURGICAL STAPLING; THORACIC SURGERY, VIDEO-ASSISTED;

EID: 33646594996     PISSN: 10107940     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejcts.2006.01.067     Document Type: Article

References (24)

1. Varela G., Jimenez M.F., Novoa N., and Aranda J.L. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg 27 (2005) 329-333
2. Fleisher A.G., Evans K.G., Nelems B., and Finley R.J. Effect of routine fibrin glue use on the duration of air leaks after lobectomy. Ann Thorac Surg 49 (1990) 133-134
3. Wong K., and Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg 64 (1997) 979-981
4. Fabian T., Federico J.A., and Ponn R.B. Fibrin glue in pulmonary resection: a prospective randomized, blinded study. Ann Thorac Surg 75 (2003) 1587-1592
5. Macchiarini P., Wain J., Almy S., and Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg 117 (1999) 751-758
6. Porte H.L., Jany T., Akkad R., Conti M., Gillet P.A., Guidat A., and Wurtz A.J. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg 71 (2001) 1618-1622
7. Wain J.C., Kaiser L.R., Johnstone D.W., Yang S.C., Wright C.D., Friedberg J.S., Feins R.H., Heitmiller R.F., Mathisen D.J., and Selwyn M.R. Trial of a novel synthetic sealant in preventing air leaks after lung resection. Ann Thorac Surg 71 (2001) 1623-1628
8. Allen M.S., Wood D.E., Hawkinson R.W., Harpole D.H., McKenna R.J., Walsh G.L., Vallieres E., Miller D.L., Nichols III F.C., Smythe W.R., Davis R.D., and 3M Surgical Sealant Group. Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection. Ann Thorac Surg 77 (2004) 1792-1801
9. Lang G., Csekeo A., Stamatis G., Lampld L., Hagman L., Martaa G.M., Mueller M.R., and Klepetko W. Efficacy and safety of topical application of human fibrinogen/thrombin-coated collagen patch (TachoComb) for treatment of air leakage after standard lobectomy. Eur J Cardiothorac Surg 25 (2004) 160-166
10. Hazelrigg S.R., Boley T.M., Naunheim K.S., Magee M.J., Lawyer C., Henkle J.Q., and Keller C.N. Effect of bovine pericardial strips on air leak after stapled pulmonary resection. Ann Thorac Surg 63 (1997) 1573-1575
11. Venuta F., Rendina E.A., De Giacomo T., Flaishman I., Guarino E., Ciccone A.M., and Ricci C. Technique to reduce air leaks after pulmonary lobectomy. Eur J Cardiothorac Surg 13 (1998) 361-364
12. Stammberger U., Klepetko W., Stamatis G., Hamacher J., Schmid R.A., Wisser W., Hillerjan L., and Weder W. Buttressing the staple line in lung volume reduction surgery: a randomized three-center study. Ann Thorac Surg 70 (2000) 1820-1825
13. Miller Jr. J.I., Landreneau R.J., Wright C.E., Santucci T.S., and Sammons B.H. A comparative study of buttressed versus nonbuttressed staple line in pulmonary resections. Ann Thorac Surg 71 (2001) 319-322
14. Loi No 88-1138 relative à la protection des personnes qui se prêtent à des recherches biomédicales du 20.12.1988. J Officiel 1988.
15. Vaughn C.C., Vaughn P.L., Vaughn III C.C., Sawyer P., Manning M., Anderson D., Roseman L., and Herbst T.J. Tissue response to biomaterials used for staple-line reinforcement in lung resection: a comparison between expanded polytetrafluoroethylene and bovine pericardium. Eur J Cardiothorac Surg 13 (1998) 259-265
16. Ahmed S., Marzouk K., Bhuiya T., Iqbal M., and Rossol L. Asymptomatic expectoration of surgical staples complicating lung volume reduction surgery. Chest 119 (2001) 307-308
17. Oey I.F., and Waller D.A. Metalloptysis: a late complication of lung volume reduction surgery. Ann Thorac Surg 71 (2001) 1694-1695
18. Shamji M., Maziak D., Shamji F., Matzinger F., and Perkins G. Surgical staple metalloptysis after apical bullectomy: a reaction to bovine pericardium?. Ann Thorac Surg 74 (2002) 258-261
19. Provencher S., and Deslauriers J. Late complication of bovine pericardium patches used for lung volume reduction surgery. Eur J Cardiothorac Surg 23 (2003) 1059-1061
20. Yates D.R., Martin-Ucar A.E., and Vaughan R. Another case of metalloptysis after lung volume reduction surgery. Ann Thorac Surg 75 (2003) 636-637
21. Oey I.F., Jeyapalan K., Entwisle J.J., and Waller D.A. Pseudo tumors of the lung after lung volume reduction surgery. Ann Thorac Surg 77 (2004) 1094-1096
22. Stammberger U., Klepetko W., Stamatis G., Hamacher J., Schmid R.A., Wisser W., Hillerjan L., and Weder W. Buttressing the staple line in lung volume reduction surgery: a randomized three-center study. Ann Thorac Surg 70 (2000) 1820-1825
23. Brunelli A., Al Refai M., Monteverde M., Borri A., Salati M., Sabbatini A., and Fianchini A. Pleural tent after upper lobectomy: a randomized study of efficacy and duration of effect. Ann Thorac Surg 74 (2002) 1958-1962
24. Alfonso N., Tan C., Utley M., Cameron R., Dussek J., Lang-Lazdunski L., and Treasure T. A prospective randomized controlled trial of suction versus non-suction to the under-water seal drains following lung resection. Eur J Cardiothorac Surg 27 (2005) 391-394