ABSTRACT
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.
ABSTRACT
BACKGROUND: Recent evidence demonstrates an association between duration of storage of red blood cells (RBC) and morbidity and mortality after cardiac surgery. We studied the feasibility of two different schemes for categorizing and randomizing age of RBC units transfused in cardiac surgical patients. STUDY DESIGN AND METHODS: In Phase 1, 20 subjects were randomly assigned to standard of care (SOC) versus no RBCs with more than 21 days' storage duration. In Phase 2, 23 subjects were randomized to RBCs of 7 +/- 4 versus 21 +/- 4 days' storage duration. The age of study RBC units was masked. RESULTS: In Phase 1, no patients received RBCs 31 days or older in SOC, and there was overlap in storage age shared in both arms so the predefined feasibility criteria were not met. In Phase 2, it was feasible to deliver specified age RBCs to the 7-day arm (achieved in 100% of subjects), but feasibility was not demonstrated for the 21-day arm (only 50% of subjects transfused with target age RBCs). Significant differences, however, were observed between the 7 +/- 4- and 21 +/- 4-day arms with respect to age of all RBC units (6 +/- 2 vs. 18 +/- 7, p = 0.0002) and maximum age (7 +/- 2 vs. 20 +/- 7, p < 0.0001). CONCLUSION: Given the current storage age distribution of available RBC inventory, use of a SOC arm in future studies is unlikely to result in a large exposure to "old" blood. It is feasible to randomize patients to "younger" RBCs (3-11 days) but design strategies are needed to provide "intermediate-aged" or "old" blood as a comparator.
