Abstract:
Objective : To compare the time of drain removal in the patients with early stage of breast cancer treated by modified radical mastectomy between the use of fibrin sealant and placebo. Design : A randomized placebo controlled clinical study. Setting : Phramongkutklao Hospital Patients : 64 patients diagnosed of stge I or II of breast cancer with fulfillment of criteria were enrolled in the study. The patients were randomly divided into fibrin sealant treated group and control group. The fibrin sealant treated group consisted of 30 patients while the control groups consisted of 34 patients. Intervention : Both groups were treated with modified radical mastectomy. Before closing the incision, in the treated group, 2 ml. of 250-IU fibrin sealant were applied over the operative area and in the control group, 2 ml. of normal saline were applied. The time of drain removal, length of hospitalization, post-catherter removal collection and other complicationswere measured. Results : It took approximately 8 days for fibrin sealant grop and 9 days for control group before the drain could be removed. Although fibrin sealant could reduce the period of drain insertion, there is no significant difference between this main measurement of clinical outcome. The patients in the fibrin sealant treated group stayed in the hospital for 9 days which is approximately a day shorter than that of the patients in the control group, however, there is no significant difference. The collection of fluid under skin flap was recorded on the first day after removing the drain and also at 4 weeks after the operation. Without significant difference, the fluid collection was detected in 33.33% of the patients in fibrin sealant treated group and 23.5% in the control group. No severe side effect of the fibrin sealant was detected. Conclusions : The result of using fibrin sealant in modified radical mastectomy showed no significant difference to the placebo in terms of the time of drain removal. The effectiveness might be a result of the amount of fibrin sealant, area of application and the application devices. Further studies to determine the importance of these factors should be done to provide proper usage of this preparation before routine clinical usage will be recommended
