In recent years, the application of fibrin sealant has been shown to be efficacious in the management of intraoperative and postoperative hemostasis. We designed a prospective randomized controlled clinical trial to assess the efficacy of two different dosages of fibrin sealant (5 and 10 ml) in patients undergoing total knee arthroplasty, as compared with the untreated control group. A total of 90 patients entered the study, randomly assigned to one of the three groups: treatment with 5 ml fibrin sealant (30 patients), with 10 ml fibrin sealant (30 patients) or no treatment (30 patients). A statistically significant difference in the mean reduction of hemoglobin concentrations was found on the first postoperative day in the treated groups as compared with the controls: 5 ml fibrin sealant (2.6 mg/dl) and 10 ml fibrin sealant (2.5 mg/dl) vs. controls (3.7 mg/dl) (P = 0.024). The mean number of blood transfusions was significantly lower in the treated groups: 5 ml (0.5) and 10 ml (0.3) of fibrin sealant vs. controls (1) (P = 0.0019). Functional recovery was also better in the treated groups: on the seventh day, the joint ROM (range of motion) was statistically superior in the 5 ml group (96.5°) and 10 ml group (98.8°) as compared with the controls (75.5°) (P < 0.0001). This study supports the efficacy of administering fibrin sealant in the perioperative management of bleeding after total knee arthroplasty and shows that a 5 ml dosage yields a comparable outcome to the 10 ml dosage previously reported in the literature.

Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty.

NOTARNICOLA, ANGELA;TAFURI, SILVIO;PESCE, Vito;MORETTI, Biagio
2012

Abstract

In recent years, the application of fibrin sealant has been shown to be efficacious in the management of intraoperative and postoperative hemostasis. We designed a prospective randomized controlled clinical trial to assess the efficacy of two different dosages of fibrin sealant (5 and 10 ml) in patients undergoing total knee arthroplasty, as compared with the untreated control group. A total of 90 patients entered the study, randomly assigned to one of the three groups: treatment with 5 ml fibrin sealant (30 patients), with 10 ml fibrin sealant (30 patients) or no treatment (30 patients). A statistically significant difference in the mean reduction of hemoglobin concentrations was found on the first postoperative day in the treated groups as compared with the controls: 5 ml fibrin sealant (2.6 mg/dl) and 10 ml fibrin sealant (2.5 mg/dl) vs. controls (3.7 mg/dl) (P = 0.024). The mean number of blood transfusions was significantly lower in the treated groups: 5 ml (0.5) and 10 ml (0.3) of fibrin sealant vs. controls (1) (P = 0.0019). Functional recovery was also better in the treated groups: on the seventh day, the joint ROM (range of motion) was statistically superior in the 5 ml group (96.5°) and 10 ml group (98.8°) as compared with the controls (75.5°) (P < 0.0001). This study supports the efficacy of administering fibrin sealant in the perioperative management of bleeding after total knee arthroplasty and shows that a 5 ml dosage yields a comparable outcome to the 10 ml dosage previously reported in the literature.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11586/102695
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