Effect of a water-soluble alkylene oxide copolymer based bone hemostat in cardiac surgery: a prospective, multicenter, single-arm study

Objectives

This study evaluated the safety and effectiveness of an Alkylene Oxide Copolymer, Ostene, in controlling bone bleeding in open cardiac surgical patients undergoing median sternotomy.

Design

Single arm, prospective, post-market study.

Setting

This study was conducted at 3 centers in the United States.

Participants

Ninety adult median sternotomy patients in whom Ostene was intended to be bone hemostat.

Interventions

Ostene used to treat bone bleeding during surgical procedure.

Measurements and main results

Surgical parameters included the area of bone bleeding, severity of bleeding, quantity of Ostene used to stop bone bleeding, time for bone bleeding to stop, time to occurrence of a bone rebleed, and the number of Ostene applications. The use and rationale for using an alternate bone hemostat were also recorded in cases where alternate bone hemostats were used. Adverse events that started from the time of the index procedure until 30 days postoperatively were also recorded.

Main results

Intraoperative bone bleeding was successfully controlled with the application of Ostene in 87 of 89 patients (97.8%) who were eligible for effectiveness analyses. Intraoperative rebleeds were observed in 23 of 90 patients (25.6%) 238.1 ± 61.7 min after hemostasis of the original bleed was achieved. Final hemostasis was achieved by reapplying Ostene in 21 patients and alternate bone hemostats in 2 of the 23 patients. None of the patients in the study had postoperative bone bleeding within 24 h of surgery. Few AEs occurred in the study cohort, all unrelated to Ostene.

Conclusions

Ostene proved to be effective bone hemostat for the control of intraoperative bone bleeding in cardiac surgical patients undergoing median sternotomy.