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Triclosan-coated sutures reduce the incidence of surgical site infections and intrabdominal infection: a double-blind randomized controlled trial.

Status Approved

  • First Submitted Date

    2021/03/09

  • Registered Date

    2021/03/16

  • Last Updated Date

    2021/03/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006009
    Unique Protocol ID GDIRB2014-01
    Public/Brief Title Triclosan-coated sutures reduce the incidence of surgical site infections and intrabdominal infection: a double-blind randomized controlled trial.
    Scientific Title Triclosan-coated sutures reduce the incidence of surgical site infections and intrabdominal infection: a double-blind randomized controlled trial.
    Acronym Vicryl
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number GDIRB2014-01
    Approval Date 2014-02-18
    Institutional Review Board Name Gachon University Gil medical Center Institutainal Review Board
    Institutional Review Board Address 21, Namdong-Daero 774 Beon-Gil Namdong-Gu, Incheon 21565 Republic of Korea
    Institutional Review Board Telephone 032-460-9464
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Won-Suk lLee
    Title professor
    Telephone +82-32-460-2765
    Affiliation Gachon University Gil Medical Center
    Address 21, Namdong-Daero 774 Beon-Gil Namdong-Gu, Incheon 21565 Republic of Korea
    Contact Person for Public Queries
    Name Won-Suk lLee
    Title professor
    Telephone +82-32-460-2765
    Affiliation Gachon University Gil Medical Center
    Address 21, Namdong-Daero 774 Beon-Gil Namdong-Gu, Incheon 21565 Republic of Korea
    Contact Person for Updating Information
    Name HeeKeun Kang
    Title Study coordinator
    Telephone +82-32-460-9464
    Affiliation Gachon University Gil Medical Center
    Address 21, Namdong-Daero 774 Beon-Gil Namdong-Gu, Incheon 21565 Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2015-01-14 Actual
    Target Number of Participant 3348
    Primary Completion Date 2023-02-28 , Anticipated
    Study Completion Date 2023-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2015-01-14 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Gachon University Gil Medical Center
    Organization Type Medical Institute
    Project ID GDIRB2014-01
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gachon University Gil Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    [ STUDY OBJECTIVES ]
    1. PRIMARY OBJECTIVE
     1)SSI rate according to Center for Disease Control’s (CDC) definition within 30 days after surgery 
    2.SECONDARY OBJECTIVES
    1)	SSI rate at 90 days after surgery
    2)	culture proven SSI according to CDC’s definition within 30 and 90 days after surgery
    3)	additional antibiotics treated SSI according to CDC’s definition within 90 days after surgery
    4)	ASEPSIS score at days 3, 7, 30 and 90 days postoperatively(appendix 1)
    5)	Non-infections wound dehiscence within 90 days after surgery
    6)	Cost effectiveness analysis
    7)	SF-36 form to analysis patient satisfaction rate at 7 and 30 days postoperatively(appendix 2)
    8)	National Nosocomial Infections Surveillance (NNIS)13 risk index at the time of operation (appendix 3)
    9)	Clinical and subclinical wound culture analysis
    
    [ INTRODUCTION AND STUDY RATIONALE ]
    Surgical site infections (SSIs) are a major source of prolonged illness, less frequently, and a cause of death in surgical patients. With an estimated 27 million surgical procedures each year in USA, and a 2–5% rate of SSIs, approximately 300,000–500,000 SSIs can be predicted to occur annually1. They are believed to increase the risk of dying 2–11 folds, with 77% of these deaths attributed directly to the surgical site infection.2 
    Surgical site infections account for the most common cause of nosocomial infections in surgical patients, increase medical costs, and prolong hospital stays. In gastrointestinal(GI) surgery, SSIs frequently cause morbidity, with an incidence of up to 30%, as indicated by previous studies. 5 One of the reasons for the development of wound infections that has been reported in the surgical literature for many years is microbial adherence to the surface of suture material.6 Recently, to prevent microbial colonization of suture material in operative wounds, triclosan-coated polyglactin sutures with antimicrobial activity have been developed.7 Several clinical studies have demonstrated that the use of triclosan-coated polyglactin sutures leads to reduction of wound infections after various surgeries.891 Triclosan-coated sutures are commercially available and have been clinically tested in different surgical procedures with diverging results.101112 One randomized controlled trial, comparing triclosan-coated sutures with identical sutures without coating in CABG patients, failed to demonstrate a difference in the incidence of leg-wound SSI. Nakamura et al1 showed triclosan-coated polyglactin sutures reduced the incidence of wound infections and the cost of colorectal surgery. 
    The overall incidence of SSI in Korea ranged between 2.0 to 9.7%. The wide range may be due to differences in the types of surgical procedures examined, or the levels of risk factors in the patients included in the studies.13  There is not a single firm study regarding the effect of suture material and  SSI in GI surgery. The impact of SSI with different suture materials on hospital cost /patient satisfaction has not been studied extensively in overseas and in Korea.   
    The purpose of this study was to prospectively investigate whether the incidence of SSI can be reduced when triclosan-coated sutures are used for abdominal wound closures and during the GI surgery. 
    An innovative therapeutic strategy to decrease SSI is of utmost importance in order to enhance the patient satisfaction and reduce hospital stay in patients undergoing GI surgery.  Therefore, we propose a prospective study of Vicryl plus versus standard Vicryl alone to determine whether Vicryl Plus can reduce overall surgical site infection and potentially reduce overall hospital cost and increase patient satisfaction.
    
    [ STUDY DESIGN ]
    Eligible patients who provided informed consent form will be double blindly randomized to receive either Vicryl plus or standard Vicryl during the surgery.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 3348
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Triclosan-coated sutures

    Cohort/Group Description

    All wounds will be inspected by a specially trained investigator at 3 , 7 and 30 days after surgery and evaluated according to both the ASEPSIS score and the Centre for Disease Control (CDC) definition of SSI . At 7,30,90 days postoperatively, the patients will be interviewed at outpatient clinic by the same investigator, following a structured question form(SF-36 and/or ASEPSIS score, ). All the investigator involved in the follow-up of the patients will be  blinded to group allocation. If a patient reported any type of wound healing problems including dehiscence, swelling, redness or exudate, they were seen at the outpatient clinic, and the wounds were evaluated and patient records were collected. Bacterial cultures were only collected from patients with symptoms of infection, namely no surveillance cultures were collected.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    abdominal wound closures and during the GI surgery group
    Sampling Method
    Probability Sampling
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (T81.4)Infection following a procedure, NEC 

    GI SURGERY
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    1.	age ≥ 20
    2.	predocumented abdominal-CT or MRI or PET-CT
    3.	No prior history of surgery 
    4.     ECOG performance status of 0~2
    5.	adequate hepatic, renal and cardiac functions
    6.	provision of a signed written informed consent
    7.	elective GI surgery
    Exclusion Criteria
    1.	patient who refuses absorbable sutures
    2.	medical condition in which surgery cannot be tolerated
    3.      patient with contaminated wound
    4.     Famale patients who are pregnant or lactating, Women of childbearing age are not a contraceptive 
    5.     Any other clinically significant medical disease or psychiatric condition that in the 
    Investigator’s opinion
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    SSI rate according to Center for Disease Control’s (CDC) definition within 30 days after surgery
    Timepoint
    4)	ASEPSIS score at days 3, 7, 30 and 90 days postoperatively
    Secondary Outcome(s) 1
    Outcome
    collection of Adverse Event & safety
    Timepoint
    all study period
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2023. 12
    Way of Sharing To be made available at a later date
    (lws@gilhospital.com)
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