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| |  STS: Experimental Sealant Closes Air Leaks in Lung Surgery Patients By Ed Susman Special to DG News SAN DIEGO, CA -- February 10, 2003 -- An investigative sealant that is sprayed onto air leaks following pulmonary surgery appears to rapidly close the leaks better than standard measures such as sutures, staples or cautery, researchers reported here February 2nd. "This study demonstrates the safety and effectiveness of a biodegradable polymer when used as an adjunct to standard closure methods for sealing significant intraoperative air leaks that develop from pulmonary surgery," said Mark Allen, MD, head of general thoracic surgery at the Mayo Clinic, Rochester, Minnesota, speaking at the 39th Annual Meeting of the Society of Thoracic Surgeons. Use of the sealant led to a reduction in post-operative air leaks, which may have decreased the length of hospitalisation, said Dr. Allen who reported results from the multicenter, prospective, randomised study that was funded by the manufacturer of the sealant, 3M Corporation. Other participating centers were the University of Washington, Seattle; Duke University Medical Center, Durham, North Carolina; Cedars Sinai Medical Center, Los Angeles, California, and the University of Texas M.D. Anderson Cancer Center, Houston. The study enrolled 273 patients, but 70 of these patients did not have any significant air leaks and another 43 patients became ineligible for randomisation due to other factors. Eventually 161 patients were randomised on a 2-to-1 basis -- 103 patients were treated with the sealant and 58 were treated with standard procedures. Results show that the spray-on sealant closed 77% of air leaks in the operating room while standard measures closes 16% of leaks, a difference that reached statistical significance at the p<0.001 level. In the recovery room, about 55% of sealant patients had no air leaks compared with 33% of patients closed with standard procedures, a difference that was significant to the p=0.002 level. Patients who received the sealant were hospitalised for an average of 6 days while those whose wounds were closed with standard measures went home after 7 days. The one day difference was judged to be statistically significant at the p=0.028 level. "The sealant was effective without any serious adverse events," Dr. Allen said. "The sealant pretty much stopped the leaks." In response to questions, Dr. Allen said that saving a day or two in hospitalisation costs would more than cover the added expense of the sealant. He said the product is expected to receive federal licensing this year. Poster 36.
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