Does the use of fibrin glue prevent seroma formation after axillary lymphadenectomy for breast cancer? A prospective randomized trial in 159 patients. New trends on fibrin glue in seroma after axillary lymphadenectomy for breast cancer. [The use of fibrin glue in the surgery of breast carcinoma]. Does fibrin sealant reduce drain output and allow earlier removal of drainage catheters in women undergoing operation for breast cancer? Fibrin glue reduces the duration of lymphatic drainage after lumpectomy and level II or III axillary lymph node dissection for breast cancer: a prospective randomized trial. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomized prospective trial. The effect of fibrin sealant combined with fibrinolysis inhibitor on reducing the amount of lymphatic leakage after axillary evacuation in breast cancer. A prospective randomized clinical trial. [Reduction of lymphatic drainage posterior to modified radical mastectomy with the application of fibrin glue]. Influence of fibrin glue on seroma formation after breast surgery. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Influence of fibrin glue on seroma formation after modified radical mastectomy: a prospective randomized study. Fibrin adhesive in radical mastectomy. Does fibrin glue improve drainage after axillary lymph node dissection? Prospective and randomized study in humans. Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial. Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Effect of fibrin glue on lymphatic drainage after modified radical mastectomy: a prospective randomized trial.
Seroma formation frequently occurs in patients who have undergone axillary lymphadenectomy. The aim of the study was to evaluate the effect of fibrin glue in the prevention of seroma formation after axillary lymphadenectomy.
                Hundred fifty-nine breast cancer patients about to undergo quadrantectomy or mastectomy plus axillary lymphadenectomy were enrolled in the study and randomized into two groups. Fibrin glue spray applied to the axillary fossa plus placement of closed suction drainage were used in 80 patients (group A); placement of closed suction drainage was only used in 79 patients (group B).
                Group A patients showed a slight advantage with regard to the mean duration of axillary drainage placement (4.5 +/- 1.3 days in group A vs. 5.1 +/- 1.6 days in group B) and number of seroma aspirations (6.3 +/- 1.1 in group A vs. 6.7 +/- 1.2 in group B). No statistically significant differences were observed between the two groups of patients regarding the mean volume of total axillary drainage and of total seroma volume.
                The use of fibrin glue does not prevent seroma formation and does not reduce seroma magnitude and duration. The costs of the product involved do not justify its routine use in patients undergoing axillary dissection. Axillary lymphadenectomy remains an integral part of breast cancer treatment, yet seroma formation occurs in 15-85% of cases. Among methods to reduce seroma magnitude and duration, fibrin glue has been proposed in several studies with controversial results.
                Ninety patients underwent quadrantectomy or mastectomy with level I/II axillary lymphadenectomy; a suction drain was fitted in all patients. Fibrin glue spray were applied to the axillary fossa in 45 patients; the other 45 patients were treated conventionally.
                Suction drainage was removed between post-operative (p.o.) days 3 and 4. Seroma magnitude and duration were significantly reduced (p 0.004 and 0.02, respectively), and there were fewer evacuative punctures, in patients receiving fibrin glue compared with the conventional treatment group.
                Use of fibrin glue does not always prevent seroma formation, but does reduce seroma magnitude, duration and evacuative punctures. Twenty-four patients operated on for breast carcinoma with associated axillary node dissection were randomly assigned to two protocols. In the first group fibrin glue was applied intraoperatively, in the second group no complementary treatment was accomplished. The aim of the study was to evaluate the effect of fibrin glue in reducing postoperative axillary sero-lymphatic secretion. In the fibrin glue group a significant reduction of postoperative axillary secretion was observed. Serosanguinous drainage after mastectomy and axillary lymph node dissection has traditionally been treated with the temporary use of closed suction drainage catheters. Use of drainage catheters is associated with wound infection, discomfort, nerve injury, and impaired arm movement. Commercially produced fibrin sealant has been proposed to reduce postoperative serosanguinous collections. We hypothesized that the intraoperative application of low-dose (2-5 cm3) fibrin sealant would reduce serosanguinous drainage and allow earlier removal of closed suction drainage catheters after operation for breast cancer. Fifty-five women with known breast cancer underwent either total mastectomy, modified radical mastectomy, or isolated level I and II axillary lymph node dissection. Twenty-six patients were treated with fibrin sealant and 29 served as control subjects. The application of fibrin sealant resulted in a significant reduction in overall duration catheters were needed (7 vs 8.3 days; P = 0.05). More importantly fibrin sealant reduced the time until 24-hour drain output was less than 30 cm3 (4.9 vs 6.2 days). Additionally fibrin sealant application resulted in a 60 per cent reduction in overall drainage amount after total mastectomy and a 32 per cent reduction after modified radical mastectomy. The application of fibrin sealant after axillary lymph node dissection did not decrease overall drainage amount. In conclusion fibrin sealant reduces serosanguinous drainage after total mastectomy and modified radical mastectomy and may allow earlier removal of closed suction drainage catheters. This randomized prospective study investigated the effect of fibrin glue use on drainage duration and overall drain output after lumpectomy and axillary dissection in breast cancer patients. A total of 100 patients undergoing breast lumpectomy and axillary dissection were randomized to a fibrin glue group (N=50; glue sprayed onto the axillary dissection site) or a control group (N=50). Outcome measures were drainage duration, overall drain output, and incidence of seroma. Overall, the fibrin glue and control groups were similar in terms of drainage duration, overall drain output, and incidence of seroma. However, subgroup analysis showed that fibrin glue use resulted in a shorter drainage duration (3.5 vs. 4.7 days; p=0.0006) and overall drain output (196 vs. 278 mL; p=0.0255) in patients undergoing level II or III axillary dissection. Fibrin glue use reduced drainage duration and overall drain output in breast cancer patients undergoing a lumpectomy and level II or III axillary dissection. Fibrin sealant (FS) has been used successfully as an effective adhesive and hemostatic agent in a variety of surgical procedures. At the University of Virginia, autologous fibrin sealant is used to reduce the potential accumulation of serous fluid after axillary dissection in patients undergoing modified radical mastectomy (MRM) for carcinoma of the breast. Unilateral MRM, including level I and II axillary lymph node dissection, was performed upon 21 patients prospectively randomized into treatment and control groups. Surgical procedures between both groups differed only by the application of autologous FS prior to axilla closure in the treatment group. Drainage was collected and measured at 24-hour intervals following the operation. Drains were removed following the measurement of 40 ml or less during a 24-hour interval. Cumulative drainage for the first 3 postoperative days in the treatment group averaged 198 +/- 83 ml compared to 467 +/- 138 ml in the control group (P < 0.0003). Day of drain removal averaged 3.9 +/- 1.7 for the treatment group and 6.9 +/- 1.2 for the control group (P < 0.0001). In the treatment group, there was a reduction in cumulative drainage over the first 3 days of 268 ml or 57 per cent, and there was a reduction in the number of days before drains can be removed of 3.0 days, or 43 per cent. We conclude that local application of FS significantly reduced the total drainage measured in patients undergoing MRM and enabled earlier drain removal. One third of women undergoing mastectomy with axillary evacuation for primary breast cancer suffer from postoperative seromas leading to unnecessary costs and complications such as infections and new operations. Different methods to prevent seroma formation have been tried without permanent success. The aim of this prospective randomised study was to examine the effect of fibrin sealant with fibrinolysis inhibitor firstly on the reduction of the amount of lymphatic leakage after axillary evacuation and secondly on the reduction of days with drains and postoperative seroma punctures.
                40 patients with primary breast cancer were prospectively randomised to the treatment group (n = 19) getting fibrin glue combined with fibrinolysis inhibitor (aprotinin) sprayed into the axillary fossa and to the control group (n = 21).
                There were no differences in the incidence of postoperative seromas between the groups. However, the seromas were easier to treat if fibrin clue was used. Total quantity (mean+/-SD) of lymphorrhea and total number of aspirations (mean+/-SD) were almost twice as high in the patients of the control group compared to those having fibrin sealant. In the treatment group seromas resolved after one or occasionally after two aspirations in 71 % of patients, while in the control group 90 % of patients needed three or more aspirations.
                Potentially, fibrin sealant combined with fibrinolysis inhibitor might be used for the treatment of post- axillary evacuation lymphorrhea and seroma. Our objective was to investigate the effectiveness of fibrin glue to reduce hemato-lymphatic fluid production after modified radical mastectomy (MRM) in women with breast cancer.
                A total of 43 women treated surgically were randomly assigned to receive 10 ml of fibrin glue at the end of the breast resection plus closed suction drains (n = 22), or drain system only as a control group (n = 23). Outcome variables were fluid collected in the drainage system measured each 24 h. Drains were removed when a 50 ml output per day was obtained. Seroma formation and flap complications were also investigated.
                The average age was 48.36 +/- 8.9 years for the study group and 52.87 +/- 9.74 years for the control group (p = 0.11). Body mass index (BMI) ranged between 22 and 35 kg/m2: 28.1 +/- 2.7 vs. 29.92 +/- 4.0 kg/m2 (p = 0.27). A reduction of the fluid drained was observed from the first postoperative day in the study group in contrast with the control (174.55 +/- 64.69 vs. 281.22 +/- 116.91, p = 0.001). A correlation between the BMI and the exposed surgical area was also statistically significant (p < 0.002), as well as the day the drains were extracted (p < 0.05). The incidence of seroma formation was 9% in the study group and 34.78% in the control, a statistically significant finding (p < 0.05).
                Fibrin glue locally applied to the surgical wound under the flap and axilla significantly reduced the amount and duration of lymphatic fluid produced after MRM with axillary dissection. Also, a significant reduction in the incidence of seromas was observed. This study was designed to determine the effectiveness of Hemaseel APR fibrin sealant versus conventional drain placement in the prevention of seromas after breast procedures.
                A prospective, randomized, controlled study of subjects who were randomized into control (drain) and experimental (fibrin) groups was conducted.
                Analysis of 82 patients showed similarly matched groups. Seroma formation rate was 45.5% in the control group and 36.8% in the fibrin glue group (P = 0.43). The rate of wound complications was similar. Aspirate volumes were significantly greater in the fibrin glue group. Drain placement saved patients >366 US dollars over fibrin glue.
                Although use of fibrin sealant resulted in a nonsignificant decrease in seroma formation rate compared with that of drain placement, the higher cost involved, cumbersome technique, and higher aspirate volumes tend to indicate that there is no advantage to using fibrin glue over drain placement with the technique described. Despite limited evidence, closed suction drainage is often used to reduce the risk of seroma formation after breast cancer surgery. The aim of this study was to evaluate the effect of drains and fibrin sealant on the incidence of seroma formation.
                A total of 116 patients undergoing surgery for breast cancer were randomized to receive suction drainage (group 1; n = 58), or to receive no drain (n = 58). Patients allocated to receive no drain were further randomized to have fibrin sealant applied to the dissected area (group 2; n = 29), or to no intervention (group 3; n = 29). Outcome measures were incidence and volume of postoperative seroma, length of hospital stay and postoperative pain scores.
                There was no significant difference in the incidence of seroma between group 1 (15 of 58) and either group with no drains (ten of 29 in group 2; 12 of 29 in group 3). There was a significant reduction in hospital stay and postoperative pain scores in patients who did not have a drain. Following mastectomy without a drain, the use of fibrin sealant was associated with a significant reduction in the incidence and total volume of seroma (190 versus 395 ml; P = 0.012).
                Drains did not prevent seroma formation, and were associated with a longer postoperative stay and higher pain scores after surgery for breast cancer. In patients who had mastectomy the use of fibrin sealant reduced the rate of seroma formation.
                Copyright 2004 British Journal of Surgery Society Ltd. nan To find out if fibrin adhesive glue applied locally would reduce the incidence of seroma after modified radical mastectomy for breast cancer.
                Prospective randomised study.
                City hospital, Sweden.
                68 women undergoing modified radical mastectomy with axillary clearance for breast cancer.
                Amount of postoperative drainage, number of seromas aspirated volumes; length of hospital stay, influence of surgeon operating.
                Seromas developed in a total of 40/68 patients (59%), 23/36 in the fibrin adhesive group (64%) and 17/32 in the control group (53%); p = 0.5 (95% confidence interval of the difference--0.13 to 0.34). There were no significant differences in the volume of aspirations or in hospital stay. The skill of the surgeon influenced the incidence of seromas, but the differences were not significant (p = 0.5).
                Local application of a fibrin adhesive glue has no effect on the incidence of seroma formation after modified radical mastectomy. The aim of this prospective and randomized study was to establish whether the use of fibrin glue was beneficial after axillary lymph node dissection. From January 1990 to January 1991, 40 women were randomized before surgery for breast cancer: 20 patients (group A) underwent vaporization of fibrin glue (Tissucol, 5 ml of 500 IU thrombin) only in the area of axillary dissection; another 20 patients (group B) served as controls. The two groups were compared for age, number of nodes removed and involved, volume and duration of fluid drainage and complications. Student's t test, Mann-Whitney nonparametric test and the chi 2 test were used when appropriate for statistical analysis. The two groups were well balanced for age, number of nodes removed and involved, staging and histologic findings. The average volume of lymphorrhea in the lymph node dissection area was greater after use of fibrin glue (410.4 ml) than in controls (275.5 ml, p = 0.016). No difference was noted between the two groups for the volume of drainage fluid of the site of mastectomy or lumpectomy, or for the total volume of drainage fluid. Drainage duration as well as duration of hospital stay were similar. Six complications occurred in group A, and one in group B (p = 0.037).(ABSTRACT TRUNCATED AT 250 WORDS) Patients who have axillary dissections during lumpectomy or modified radical mastectomy for breast carcinoma accumulate serosanguinous fluid, potentially resulting in a seroma. Currently accepted practice includes insertion of one or more drains for fluid evacuation. This multicenter, randomized, controlled, phase II study was undertaken to evaluate whether a virally inactivated, investigational fibrin sealant is safe and effective when used as a sealing agent to reduce the duration and volume of serosanguinous fluid drainage and to determine the dose response of this effect.
                Patients undergoing lumpectomy or modified radical mastectomy were randomized to treatment with 4, 8, or 16 mL of fibrin sealant or control (no agent) at the axillary dissections site. Patients undergoing modified radical mastectomy also received an additional 4 or 8 mL of fibrin sealant at the skin flap site. Efficacy was evaluated by the number of days required for wound drainage and the volume of fluid drainage compared with control. Safety was confirmed by clinical course, the absence of viral seroconversion, and no major complications attributable to the sealant.
                The 4-mL axillary dissection dose of fibrin sealant significantly reduced the duration and quantity of fluid drainage from the axilla following lumpectomy (p < or = 0.05). In the modified radical mastectomy patients, a 16-mL axillary dissection dose combined with an 8-mL skin flap dose was significantly effective in reducing the number of days to drain removal (p < or = 0.05) and fluid drainage (p < or = 0.01). There were no fibrin sealant patient viral seroconversions and no major complications attributable to the sealant. A number of wound infections were noted, although this may represent a center-specific effect.
                Application of fibrin sealant following axillary dissection at the time of lumpectomy or modified radical mastectomy can significantly decrease the duration and quantity of serosanguinous drainage. The viral safety of the product was also supported. A prospective randomized trial was carried out to evaluate the efficacy of fibrin glue in preventing lymphorrhea after axillary lymphadenectomy in breast cancer. One hundred and eight breast cancer patients, operated on by two senior surgeons, were randomized into two groups: group 1 (n = 58) without fibrin glue and group 2 (n = 50) with 2 ml of fibrin glue applied to the axillary dissection area at the end of the lymphadenectomy procedure. Early postoperative morbidity was 2/58 and 0/50 in groups 1 and 2, respectively. Mean daily postoperative drainage was significantly greater in group 1. The mean cumulative drainage quantity 6 days after the operation was 407.8 ml and 214.4 ml in groups 1 and 2, respectively (p = 0.001). The mean postoperative hospital stay was 10.1 days and 8.0 days in groups 1 and 2, respectively (p = 0.006). One delayed seroma was observed in each group. Fibrin glue seems to reduce daily postoperative drainage and hospital stay, but did not affect delayed seroma formation after axillary lymphadenectomy for breast cancer. Seroma formation is a frequently occurring complication in patients operated on because of breast cancer. This complication can be the cause of flap necrosis, can lead to infection, and can prolong the hospital stay. It can also cause a delay in chemotherapy and radiotherapy. In order to prevent seroma formation, various methods such as external compression dressings, immobilization of the arm, sclerotherapy, and suction drainage have been used, without much success. In animal models and some clinical studies, it has been stated that fibrin glue reduces seroma formation, and these statements generated high expectations. For this reason, a prospective study was planned to test this in patients who underwent modified radical mastectomy (MRM) because of breast cancer. Of the 54 patients studied, 27 patients had fibrin glue (4 ml) applied to wound surfaces and under the flap (study group); the remaining 27 patients were the control group. Daily drainage volumes, total amount of drainage, drain removal time, and seroma formation were recorded and compared between the two groups. The first-day drainage was significantly lower in the study group (p<0.05, Student's t-test). There were no significant differences in daily drainage volumes, drain removal time, seroma formation frequency, and the number of seromas between the two groups (p>0.05). In conclusion; fibrin glue application had no significant benefit on axillary lymphatic drainage, drain removal time, or seroma formation. Fibrin as a tissue sealant has been used since the turn of the century for hemostasis. The development of cryoprecipitate and the resultant availability of higher concentrations of fibrinogen have led to a resurgence of interest in this material. Fibrin glue has since been shown to be effective for numerous applications throughout the field of surgery. Animal studies have shown fibrin glue to be effective at reducing drain output after mastectomy. Human studies, however, have been equivocal. Our objectives were to determine whether the use of fibrin glue would decrease lymphatic drainage after modified radical mastectomy and subsequently reduce time to drain removal. A prospective randomized trial was conducted consisting of 27 women. All women received modified radical mastectomy. At the completion of the mastectomy they were randomized to receive either standard closure or the application of fibrin glue before standard closure. Patients were then monitored for daily drain output, time to drain removal, and wound complications. A total of 14 women received fibrin glue and 13 received no glue. Those patients receiving fibrin glue had a significantly higher average drain output than patients who did not receive glue (1308 vs 754 cm3; P = 0.012). Time to drain removal was also increased by 4 days, although this did not reach statistical significance. The overall complication rate was higher for the fibrin glue group, although again, this did not reach significance. The application of fibrin glue significantly increased drain total drain output after modified radical mastectomy. Time to drain removal was increased as was the complication rate. On the basis of these data fibrin glue cannot be recommended for routine use in modified radical mastectomy.
FG did not influence the incidence of postoperative seroma, the mean volume of seroma, wound infections, complications and the length of hospital stays in people undergoing breast cancer surgery. Due to significant methodological and clinical diversity among the included studies this conclusion may be considered weak and biased. Therefore, a major multicentre and high-quality RCT is required to validate these findings.