OBJECTIVE:Postoperative sternal wound complications are a significant problem in high-risk patients. In addition to closure with conventional wires, several systems involving rigid fixation with metal plates are currently available. The rapid sternal closure system (Talon) is approved for stabilization and fixation of the anterior chest wall. Anecdotal evidence suggests that use of the Talon may result in improved postoperative recovery. METHODS:Fifty-one cardiac surgical patients at higher risk for sternal wound complications were enrolled at two sites. Subjects were randomized to insertion of Talons (n = 28) or wires only (control, n = 23) for sternal closure. The primary endpoint was a comparison between study groups of the percent of baseline incentive spirometry volume through postoperative day 7. Secondary endpoints included other measures of quality of recovery, sternal wound infection, and nonunion. RESULTS: The percentage of preoperative incentive spirometry volume achieved was higher in the Talon arm (67% ± 32%) versus control (58% ± 24%); however, this was not statistically significant (P = 0.41). Use of the Talon was associated with decreased use of opiates (21.3 ± 11.8 vs. 25.4 ± 21.6 mg, P = 0.44), increased ability to ambulate 1000 ft on postoperative day 5 (25% vs. 13%, P = 0.28), and decreased duration of mechanical ventilation (median 0.5 vs 1.0 days, P = 0.24) and hospital length of stay (4.5 ± 3.2 vs. 5.3 ± 4.0 days, P = 0.40). One superficial sternal wound infection was observed in each study arm. There were no cases of nonunion. CONCLUSIONS: In this pilot study, the primary endpoint was not statistically different between the treatment groups. Use of the Talon was associated with trends toward benefit in endpoints consistent with enhanced postoperative recovery, highlighting a need for additional data from larger randomized trials.
RCT Entities:
OBJECTIVE: Postoperative sternal wound complications are a significant problem in high-risk patients. In addition to closure with conventional wires, several systems involving rigid fixation with metal plates are currently available. The rapid sternal closure system (Talon) is approved for stabilization and fixation of the anterior chest wall. Anecdotal evidence suggests that use of the Talon may result in improved postoperative recovery. METHODS: Fifty-one cardiac surgical patients at higher risk for sternal wound complications were enrolled at two sites. Subjects were randomized to insertion of Talons (n = 28) or wires only (control, n = 23) for sternal closure. The primary endpoint was a comparison between study groups of the percent of baseline incentive spirometry volume through postoperative day 7. Secondary endpoints included other measures of quality of recovery, sternal wound infection, and nonunion. RESULTS: The percentage of preoperative incentive spirometry volume achieved was higher in the Talon arm (67% ± 32%) versus control (58% ± 24%); however, this was not statistically significant (P = 0.41). Use of the Talon was associated with decreased use of opiates (21.3 ± 11.8 vs. 25.4 ± 21.6 mg, P = 0.44), increased ability to ambulate 1000 ft on postoperative day 5 (25% vs. 13%, P = 0.28), and decreased duration of mechanical ventilation (median 0.5 vs 1.0 days, P = 0.24) and hospital length of stay (4.5 ± 3.2 vs. 5.3 ± 4.0 days, P = 0.40). One superficial sternal wound infection was observed in each study arm. There were no cases of nonunion. CONCLUSIONS: In this pilot study, the primary endpoint was not statistically different between the treatment groups. Use of the Talon was associated with trends toward benefit in endpoints consistent with enhanced postoperative recovery, highlighting a need for additional data from larger randomized trials.