Effects of Early Postoperative Showering After Coronary A... | NCT06237283

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

NCT06237283

Sponsor

Sejong General Hospital

Status

Unknown status

Last Update Posted

Feb 2, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Wounds and Injuries
Wound Infection

Interventions

Early shower

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2024Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Jan 23, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Feb 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2024

Last Update Posted Date

Feb 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early shower	Experimental	Start shower after drain removal	Behavioral: Early shower
Late shower	No Intervention	Start shower after wound stitches are removed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early shower	Behavioral	Start shower after drain removal	Early shower

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of deep sternal wound infection		until 1 months after discharge
Rate of superficial sternal wound infection		until 1 months after discharge
Rate of wound dehiscence		until 1 months after discharge

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	questionnaire	at 1st outpatient clinic visit
Rate of mortality		until 1 months after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bucheon Sejong Hospital	Recruiting	Bucheon-si	Gyeonggi-do	14754	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D014946	Wound Infection

Ancestor Terms

ID	Term
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided