- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237283
Effects of Early Postoperative Showering After Coronary Artery Bypass Grafting Using Bilateral Internal Thoracic Artery
January 31, 2024 updated by: Sejong General Hospital
The study to evaluate effects of early postoperative showering after coronary artery bypass grafting using bilateral internal thoracic artery
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HEEMOON LEE
- Phone Number: 82-10-9083-6249
- Email: rhythmists@gmail.com
Study Contact Backup
- Name: KyuWon Kang
- Phone Number: 82-10-2276-8479
- Email: rbdnjs9707@daum.net
Study Locations
-
-
Gyeonggi-do
-
Bucheon, Gyeonggi-do, Korea, Republic of, 14754
- Recruiting
- Bucheon Sejong Hospital
-
Contact:
- HEEMOON LEE
- Phone Number: 82-10-9083-6249
- Email: rhythmists@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age > 18
- Patients who underwent coronary bypass grafting with bilateral internal thoracic artery through median sternotomy
- Patients whose all drains or pacing wires are removed
Exclusion Criteria:
- Concomitant operation
- Redo-surgery
- prolonged intensive care unit stay (more than 4 days) due to serious complications after surgery
- open wounds
- active infection
- prolonged drains
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early shower
Start shower after drain removal
|
Start shower after drain removal
|
|
No Intervention: Late shower
Start shower after wound stitches are removed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of deep sternal wound infection
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
Rate of superficial sternal wound infection
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
Rate of wound dehiscence
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: at 1st outpatient clinic visit
|
questionnaire
|
at 1st outpatient clinic visit
|
|
Rate of mortality
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
|
Rate of stroke
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
|
Rate of respiratory complications
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
|
Rate of bleeding requiring reoperation
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
|
|
Rate of low cardiac output syndrome
Time Frame: until 1 months after discharge
|
until 1 months after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
January 23, 2024
First Submitted That Met QC Criteria
January 23, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSH 2023-09-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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