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RecruitingNCT06237283Updated Feb 2, 2024

Effects of Early Postoperative Showering After Coronary Artery Bypass Grafting Using Bilateral Internal Thoracic Artery

An interventional study of Early shower in Wounds and Injuries and Wound Infection, sponsored by Sejong General Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Sejong General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The study to evaluate effects of early postoperative showering after coronary artery bypass grafting using bilateral internal thoracic artery

02

Conditions studied

  • Wounds and Injuries
  • Wound Infection
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Early shower

    Start shower after drain removal

    Behavioral: Early shower

  • No intervention
    Late shower

    Start shower after wound stitches are removed

Interventions

  • BehavioralEarly shower

    Start shower after drain removal

05

What researchers measure

Primary outcomes

  1. Rate of deep sternal wound infection

    Time frame: until 1 months after discharge

  2. Rate of superficial sternal wound infection

    Time frame: until 1 months after discharge

  3. Rate of wound dehiscence

    Time frame: until 1 months after discharge

Secondary outcomes

  1. Patient satisfaction

    questionnaire

    Time frame: at 1st outpatient clinic visit

  2. Rate of mortality

    Time frame: until 1 months after discharge

  3. Rate of stroke

    Time frame: until 1 months after discharge

  4. Rate of respiratory complications

    Time frame: until 1 months after discharge

  5. Rate of bleeding requiring reoperation

    Time frame: until 1 months after discharge

  6. Rate of low cardiac output syndrome

    Time frame: until 1 months after discharge

06

Study locations

1 of 1 sites recruiting
  • Bucheon Sejong Hospital
    Bucheon, Gyeonggi-do 14754, Korea, Republic of
    Recruiting
07

Registry details

Key details

Study ID
NCT06237283
Lead sponsor
Sejong General Hospital
Responsible party
Sponsor
First posted
Feb 1, 2024
Start date
Jan 3, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Feb 2, 2024

Study contacts

HEEMOON LEE
Contact
rhythmists@gmail.com
82-10-9083-6249
KyuWon Kang
Contact
rbdnjs9707@daum.net
82-10-2276-8479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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