A prospective randomized study to assess the efficacy of a surgical sealant to treat air leaks in lung surgery.
OBJECTIVE
A prospective, randomized study to evaluate the effectiveness and safety of a polymeric sealant (Coseal, Baxter Healthcare, Deerfield, IL) to reduce air leaks and to improve postoperative outcome in patients undergoing lung resection.


METHODS
Between November 2005 and February 2008, 203 (128 M, 75 F) patients showing moderate/severe intraoperative air leaks after pulmonary lobectomy/bilobectomy/sleeve lobectomy (110) or minor resection (segmentectomy/wedge) (93) have been prospectively enrolled and randomly assigned to receive one of the two following management strategies: suture/stapling (101 patients--standard care group (SCG)) or suture/stapling plus Coseal sealant (102 patients--Coseal group (CG)). To assess the effectiveness of the sealant the following data were registered and compared in the two groups: number of patients with air leak cessation intraoperatively, number of patients without air leaks at 24h and 48h, duration of air leaks, length of hospital stay.


RESULTS
No adverse event related to the sealant application occurred. Intraoperative air leak cessation rate was higher in the CG with a statistically significant difference (85.3% vs 59.4%; p<0.001). Air leaks rate at 24h and 48h was significantly lower in the Coseal group (19.6% vs 40.6%; p=0.001 at 24h and 23.5% vs 41.6%; p=0.006 at 48h). Duration of air leaks was significantly shorter in the Coseal group (p=0.01). The hospital stay was shorter in the Coseal group (mean: 5.7+/-2.3 days vs 6.2+/-2.5 days) but this difference did not reach statistical significance owing to the many known clinical interfering factors.


CONCLUSIONS
The application of Coseal sealant proved safe and effective in reducing air leaks occurring after lung resection and in shortening the duration of postoperative air leak with a trend towards a shorter postoperative hospital stay.
D'Andrilli
Antonio
A
Department of Thoracic Surgery, University of Rome La Sapienza, Sant'Andrea Hospital, Rome, Italy. adandrilli@hotmail.com
Andreetti
Claudio
C
Ibrahim
Mohsen
M
Ciccone
Anna Maria
AM
Venuta
Federico
F
Mansmann
Ulrich
U
Rendina
Erino Angelo
EA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000379:methods; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000379:methods; D011030:Pneumothorax / Q000209:etiology / Q000628:therapy*; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D017792:Surgical Stapling; D013537:Sutures; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
C513322:CoSeal; D014014:Tissue Adhesives; D011092:Polyethylene Glycols