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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05206929
Other study ID # IRB20-1339
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 2025

Study information

Verified date March 2024
Source University of Chicago
Contact Carlisa Dixon
Phone 773-834-4337
Email cdixon520@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date June 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Other:
Self Managed Care
Self Managed Care

Locations

Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sternal Precaution Checklist Assessing patients' adherence to protocol Patient will be called weekly for 8 weeks by a medical professional.
Secondary Sternal Precautions- Quality of Life Questions Assessing patients' postoperative quality of life Patient will be called weekly for 8 weeks by a medical professional.
Secondary Sternal Precaution Pain Scale Assessing patients' postoperative pain Patient will be called weekly for 8 weeks by a medical professional.
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