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

NCT05206929 | Terminated

• 1 other identifier: IRB20-1339
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Heart Diseases; Heart Failure; Cardiac Valve Disease

Outcome Measures

Primary Outcomes (1)

• Sternal Precaution Checklist

  Assessing patients' adherence to protocol

  Patient will be called weekly for 8 weeks by a medical professional.

Secondary Outcomes (2)

• Sternal Precautions- Quality of Life Questions

  Patient will be called weekly for 8 weeks by a medical professional.

• Sternal Precaution Pain Scale

  Patient will be called weekly for 8 weeks by a medical professional.

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

Other: Self Managed Care

Arm 2

ACTIVE COMPARATOR

Arm 2 will receive the standard sternal precautions at time of post operative discharge.

Other: Self Managed Care

Interventions

Self Managed Care OTHER

Self Managed Care

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Valluvan Jeevanandam, MD

  Professor of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 25, 2022
• Study Start: June 1, 2021
• Primary Completion: November 21, 2022
• Study Completion: October 30, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)