SurgeryNCT05206929
Prescribed Sternal Precautions vs. Self-Guided Restrictive Care (PEEERC)
A study testing Self Managed Care in people with Surgery and Heart Diseases, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery, Heart Diseases, Heart Failure
- What is being tested?
- Self Managed Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently
Who cannot join
- Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
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.
Read the 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
- Being tested
- Self Managed Care
- Medical subject headings
- Heart Diseases, Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Managed CareOther
Self Managed Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self Managed Care |
| Arm 2 | Active comparator | Arm 2 will receive the standard sternal precautions at time of post operative discharge. Receives: Other: Self Managed Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal Precaution Checklist
Assessing patients' adherence to protocol
Measured: Patient will be called weekly for 8 weeks by a medical professional.
Secondary outcomes (2)
Sternal Precautions- Quality of Life Questions
Assessing patients' postoperative quality of life
Measured: Patient will be called weekly for 8 weeks by a medical professional.
Sternal Precaution Pain Scale
Assessing patients' postoperative pain
Measured: Patient will be called weekly for 8 weeks by a medical professional.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jun 2021
- Primary completion21 Nov 2022
- Study completion30 Oct 2025
Why it stopped: Lack of current personnel availability. Plan to re-evaluate the study protocol and potentially reconsider study alterations in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valluvan Jeevanandam, MD, Principal investigator, Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206929
- Sponsor's protocol ID
- IRB20-1339
- Status last verified
- Nov 2025
- First submitted
- 12 Jan 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
- ClinicalTrials.gov ID
- NCT05206929
- Acronym / sponsor ID
- IRB20-1339
- Conditions
- Surgery, Heart Diseases, Heart Failure, Cardiac Valve Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of current personnel availability. Plan to re-evaluate the study protocol and potentially reconsider study alterations in the future.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Self Managed CareArm 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. |
| Arm 2 | Active comparator | Other: Self Managed CareArm 2 will receive the standard sternal precautions at time of post operative discharge. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently
Key exclusion criteria (1 listed)
- Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Managed CareSelf Managed Care | Other | Arm 1, Arm 2 |
Primary outcome
Sternal Precaution Checklist
Time frame: Patient will be called weekly for 8 weeks by a medical professional.
Assessing patients' adherence to protocol
2 secondary outcomes
Sternal Precautions- Quality of Life Questions
Time frame: Patient will be called weekly for 8 weeks by a medical professional.
Sternal Precaution Pain Scale
Time frame: Patient will be called weekly for 8 weeks by a medical professional.
Results and safety
The study was stopped early (reason given: Lack of current personnel availability. Plan to re-evaluate the study protocol and potentially reconsider study alterations in the future.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valluvan Jeevanandam, MD principal investigator
Professor of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Managed Care in people with Surgery and Heart Diseases, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of current personnel availability. Plan to re-evaluate the study protocol and potentially reconsider study alterations in the future.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal Precaution Checklist (time frame: Patient will be called weekly for 8 weeks by a medical professional.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.