NCT05206929

Prescribed Sternal Precautions vs. Self-Guided Restrictive Care (PEEERC)

A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.

Detailed description

Patients who are recruited in this study will be randomized (1:1) into one of two groups/arms. The ?rst arm (Arm 1) will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge. The second arm (Arm 2) will receive the standard sternal precautions at time of post operative discharge. Standard sternal precautions in study arm (2) include: Don't reach both arms overhead Don't reach both arms out to the side Don't reach behind your back Don't lift more than 5 to 8 pounds Don't push with your arms Don't pull with your arms Don't drive Each arm will receive weekly phone calls for 8 weeks. Information including pain, quality of life, and adherence to the sternal precaution protocol will be collected. Please refer to supporting documents (Pain Scale, Quality of Life Questionnaire, and Sternal Precaution Checklist) for the specific questions that will be asked at the patients. We will also investigate any adverse events related to the medical care.

Conditions

• Surgery
• Heart Diseases
• Heart Failure
• Cardiac Valve Disease

Interventions

Type	Name	Description
OTHER	Self Managed Care	Self Managed Care

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-11-21
• Completion: 2025-10-30
• First posted: 2022-01-25
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States