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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206929
Enrollment
10
Registered
2022-01-25
Start date
2021-06-01
Completion date
2025-10-30
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Valve Disease, Heart Diseases, Heart Failure, Surgery

Brief 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.

Interventions

OTHERSelf Managed Care

Self Managed Care

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

1:1 randomization

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently

Exclusion criteria

* Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy

Design outcomes

Primary

MeasureTime frameDescription
Sternal Precaution ChecklistPatient will be called weekly for 8 weeks by a medical professional.Assessing patients' adherence to protocol

Secondary

MeasureTime frameDescription
Sternal Precautions- Quality of Life QuestionsPatient will be called weekly for 8 weeks by a medical professional.Assessing patients' postoperative quality of life
Sternal Precaution Pain ScalePatient will be called weekly for 8 weeks by a medical professional.Assessing patients' postoperative pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026