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

NCT ID: NCT05206929

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Surgery Heart Diseases Heart Failure Cardiac Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1

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.

Group Type EXPERIMENTAL

Self Managed Care

Intervention Type OTHER

Self Managed Care

Arm 2

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

Group Type ACTIVE_COMPARATOR

Self Managed Care

Intervention Type OTHER

Self Managed Care

Interventions

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Self Managed Care

Self Managed Care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valluvan Jeevanandam, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB20-1339

Identifier Type: -

Identifier Source: org_study_id