The Effectiveness of Central Venous Catheter Securement with Topical Tissue Adhesive in Patient Undergoing Cardiac Surgery : Pilot study, A randomized Controlled Study
Study ID: TCTR20180608004
Current status: Completed
Last Updated: June 16, 2020
Tracking Information
Date of Registration in Primary Registry: June 06, 2018
Date of First Enrollment: May 16, 2018 (Actual)
Target Sample Size: 150
Last Updated Date: June 16, 2020
Primary Outcome(s):
  • Outcome name: Immediate Postoperative Bleeding af Pericatheter Site
       Metric/method of measurement: Visual Judgement by Anesthetic Personnel
       Time point: Immediate Postoperative
       Safety Issue?: Yes


  • Key Secondary Outcomes:
  • Outcome name: Catheter failure
       Metric/method of measurement: Incidence of Catheter Failure
       Time point: Within 3 Postoperative Days
       Safety Issue?: No


  • Outcome name: Total Catheter Dressing
       Metric/method of measurement: Number of Dressing per Catheter per Day
       Time point: Within 3 Postoperative Days
       Safety Issue?: No


  • Descriptive Information
    Public Title: The Effectiveness of Central Venous Catheter Securement with Topical Tissue Adhesive in Patient Undergoing Cardiac Surgery : Pilot study, A randomized Controlled Study
    Scientific Title: The Effectiveness of Central Venous Catheter Securement with Topical Tissue Adhesive in Patient Undergoing Cardiac Surgery : Pilot study, A randomized Controlled Study
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Randomized controlled trial
    Control: N/A
    Study Endpoint Classification: Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Open Label (Masked Roles: )
    Primary Purpose: Prevention
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: Patient who needs cardiac surgery
    Study Arms:
  • Arm: 1
  • Intervention Name: Topical tissue adhesive group (TTA)
    Type: Experimental
    Classification: Device
    Descriptions: Fix central venous catheter by suturing with nylon or silk, then applying Topical tissue adhesive (Dermabond®) and cover with gauze and Tegaderm®
  • Arm: 2
  • Intervention Name: Standard Dressing group (SD)
    Type: No Intervention
    Classification: No treatment
    Descriptions: Fix central venous catheter by suturing with nylon or silk, then cover with gauze and Tegaderm®
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 150
    Study Start Date (First enrollment): May 16, 2018
    Primary Completion Date: January 15, 2019
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 15 Years : Maximum 0 N/A (No limit)
    - Patient who undergoes elective cardiac surgery which needs for internal jugular central venous catheter insertion in the operating room
    - Patient’s age group > 15 years old
    - Patient who admits in postoperative cardiac intensive care unit
    Exclusion Criteria
    Patient refuses
    Patient who has a sign of infection or sepsis
    Patient who has a atopic disease

    Accept Healthy Volunteers: Yes
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Naruemol Prachanpanich
    Phone: 081-755-1137
    Email: nolruema@hotmail.com
    Postal Address: Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20180608004
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Study Primary Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Study Secondary Sponsor: 1.) N/A
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Naruemol Prachanpanich
    Phone: 081-755-1137
    Email: nolruema@hotmail.com
    Postal Address: Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
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