UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042605 |
|---|---|
| Receipt number | R000048232 |
| Scientific Title | Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2023/06/12 10:57:35 |
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Basic information
Public title
Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Acronym
Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Scientific Title
Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Scientific Title:Acronym
Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Region
| Japan |
Condition
Condition
Surgical site infection
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of antimicrobial threads in fascial closure for colorectal surgery in relation to thread type and incidence surgical site infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of surgical site infection
Key secondary outcomes
(1) Surgical site complications other than surgical site infection
(2) Post-operative hospital stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with scheduled colorectal cancer surgery
2) Patient has operable general condition and organ function.
3) Performance Status (ECOG) of either 0 or 1.
4) Written consent to participate in the study has been obtained from the patient.
Key exclusion criteria
1) There is no history of surgical wounds on the planned surgical site.
2) Do not perform surgery on other organs in different locations at the same time.
3) No history of radiation therapy or chemotherapy.
4) No contamination or infection surgery.
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Norikatsu |
| Middle name | |
| Last name | Miyoshi |
Organization
Osaka University, Graduate School of Medicine
Division name
Departments of Gastroenterological surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
nmiyoshi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Mizushima |
Organization
Osaka University, Graduate School of Medicine
Division name
Departments of Gastroenterological surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University, Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8290
jim-chiken@hp.crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/journalacs/Fulltext/2022/06000/Effectiveness_of_Triclosan_Coated_Sutures_Co
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/journalacs/Fulltext/2022/06000/Effectiveness_of_Triclosan_Coated_Sutures_Co
Number of participants that the trial has enrolled
2207
Results
The recorded SSI rates were 4.2% in the triclosan-coated group and 6.74% in the uncoated suture group (p = 0.028). There were no serious adverse events in the groups. The final logistic regression model showed that several variables affected the occurrence of SSI. Our meta-analysis included six phase-III trials, and our study evaluated 4,797 patients. The results show a significant superiority of triclosan-coated sutures over uncoated suture material.
Results date posted
| 2023 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was a multicenter prospective trial conducted within 24 Japanese secondary and tertiary care centers, and a propensity score matched analysis. Patients 20 years of age or older who underwent elective surgery for colorectal cancer were included.
Participant flow
Between July 2016 and July 2019, 2,207 patients were prospectively enrolled into the triclosan-coated sutures or uncoated sutures groups. The per-protocol population comprised 2,195 patients. The PS matching was performed for 1,579 patients: 926 patients in the coated group and 653 patients in the uncoated group.
Adverse events
Not found
Outcome measures
The primary endpoint was the incidence of an SSI. Secondary endpoints were length of hospital stay and surgical complication rates.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Starting October 4, 2016, 2200 patients will be included in the study who will undergo standby colorectal surgery for patients aged 20 years and older with PS0-1. The sutures used for fascial sutures will be absorbable sutures selected by each institution.
Management information
Registered date
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048232
