TITLE:
Posthorax® Prevents Sternal Dehiscence and Instability: Preliminary Results of a Prospective Randomized Multicenter Trial
AUTHORS:
Santarpino Giuseppe, Fischlein Theodor, Steffen Pfeiffer
KEYWORDS:
Chest Wall; Device; Wound Dehiscence; Wound Infection; Postoperative Care
JOURNAL NAME:
Open Journal of Thoracic Surgery,
Vol.3 No.2,
June
4,
2013
ABSTRACT:
Aim: A Prospective Randomized Multicenter Trial is ongoing to evaluate Posthorax and prevention of sternal dehiscence/instability: clinical percept is optimistic for Posthorax use. The aim of this mono-center analysis is to give a preliminary result of Posthorax support vest after sternotomy. Methods: One hundred and eighty three cases elective patients were consecutive operated and included in this study conducted in our department since June 2009. Patients were randomized as following: 68 patients were treated with the Posthorax support vest and 115 received a standard bandage postoperatively. The primary endpoints were the Infective Events. Secondary endpoints included a composite of postoperative clinical variables and mortality. Results: The two groups are homogeneous for these characteristic except sex (more women in Control Group, p = 0.022). Operative data were comparable in both groups. Deep sternal infections occurred in four patients, all in Control Group (3.5% vs 0%, p = 0.153). At Follow up, we recorded 2 cases of superficial infection in the control group versus 0 (1.7%, p = 0.394) and 1 case of wound dehiscence always in Control Group versus 0 (0.9%, p = 0.628). Cumulative Infective Events are statistically more in Control Group (7 cases 6.1% versus 0 cases, p = 0.036*). According to the secondary endpoints, there were also no differences between the two compared groups except length of hospitalization (10.6 ± 4 days versus 13.4 ± 9.5, p = 0.019*). Conclusion: Preliminary results show the Posthorax sternum support vest as a valuable adjunct to prevent sternum-related complications: We record a statistical reduction of length of hospital stay and infective events using the support vest in a 3-month follow-up.