Comparing standard and self-managed sternal precautions after heart surgery
A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
This study is testing if letting heart surgery patients manage their own activity based on pain helps them feel better and live more comfortably compared to following standard recovery rules.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05206929 on ClinicalTrials.gov |
What this trial studies
This study compares postoperative outcomes, pain levels, and quality of life in patients who follow standard sternal precautions versus those who use self-managed sternal precautions after undergoing sternotomy for cardiac surgeries. Participants will be randomly assigned to one of two groups: one receiving standard precautions and the other instructed to manage their activity based on pain and discomfort. Data will be collected through weekly phone surveys for eight weeks and by reviewing electronic medical records for up to a year. The goal is to determine if self-managed care can improve quality of life without increasing pain or adverse events.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18-70 who are undergoing sternotomy and can ambulate independently.
Not a fit: Patients undergoing sternotomy for VAD implantation or cardiac transplantation, or those with prior sternotomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and quality of life for patients after cardiac surgery.
How similar studies have performed: Other studies have explored self-managed care approaches, but this specific comparison of sternal precautions is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Valluvan Jeevanandam, MD — Professor of Surgery
- Study coordinator: Leila Yazdanbakhsh
- Email: leila.yazdanbakhsh@bsd.uchicgao.edu
- Phone: 773-834-5087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.