We propose a new system for sternal support using the SternaSafe device that might reduce pain. Reducing this symptom could also minimize the additional time taken from healthcare staff and the unnecessary operation of other health care resources.

To review outcomes and pain of post-median sternotomy (PMS) patients who receive a symptom management device to use during coughing.

Prospective randomized control, single arm. This is a single arm 1:1 randomized study to assess the efficacy of SternaSafe in the reduction of pain. Patients will be screened to determine eligibility prior to their scheduled surgery in an outpatient or inpatient setting. After a determination of eligibility subjects will be consented and enrolled into the study prior to hospital discharge.

At time of surgery a member of the study team will randomize the subject into one of two arms: standard of care sternal support or SternaSafe median Support system. Subjects participating in this study will have a 50/50 chance of randomizing into either arm. All patients enrolled into the study will be medically educated per standard of care guidelines prior to discharge on the use of both standard of care and SternaSafe median support systems. Subjects will be physically followed for approximately 30 days post hospital discharge..

RedCap Data entry - mentoring will be provided.

STS

AATS