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
CRIS Registration Number |
KCT0006009 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Gachon University Gil Medical Center |
Organization Type | Medical Institute |
Project ID | GDIRB2014-01 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University Gil Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | abdominal wound closures and during the GI surgery group |
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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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | SSI rate according to Center for Disease Control’s (CDC) definition within 30 days after surgery |
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Timepoint | 4) ASEPSIS score at days 3, 7, 30 and 90 days postoperatively |
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Secondary Outcome(s) 1 | ||
Outcome | collection of Adverse Event & safety |
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Timepoint | all study period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2023. 12 |
Way of Sharing | To be made available at a later date
(lws@gilhospital.com) |
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