Background. To reduce the risk of seroma after modified radical mastectomy in breast cancer patients, the use of suction axillary drainage is a standard procedure. The optimal time to remove the drain is not established. Whether the removal or preservation of the pectoral fascia influences the risk of seroma formation or loco-regional recurrence rate remains unclear. Method. The trial included 247 patients with breast cancer who underwent modified radical mastectomy in five Swedish hospitals 1993-1997. The median follow-up time was 6 years. One hundred and twenty-two and 125 patients, respectively, were randomised between removal versus preservation of the pectoral fascia. Of these 247 patients a total of 198 patients were also randomised to have the drain removed 24 h postoperatively or to keep the drain in until discharge had decreased to less than 40 ml/24 h. Results. Early removal of the axillary drain was associated with significantly more seromas and a shorter average postoperative hospital stay. There were no differences between the two groups regarding the rate of wound infections and/or hematoma formation. Removal or preservation of the pectoral fascia did not influence the formation of seroma or the amount of peroperative bleeding. A trend towards an increased risk for chest wall recurrence was observed in patients with preserved pectoral fascia (16/125 compared with 8/122; hazard ratio=2.0, 95% confidence interval=0.9-4.7). Conclusion. Early removal of axillary drain shortened the duration of hospital stay without any increase in wound complications. However, it yielded a significantly higher incidence of seroma. Seroma formation and the chest wall recurrence rate was not significantly influenced by the preservation of the pectoral fascia or not. © 2004 Elsevier Ltd. All rights reserved.
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