UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054324 |
|---|---|
| Receipt number | R000061983 |
| Scientific Title | Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/07 07:05:20 |
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Basic information
Public title
Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery
Acronym
Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery
Scientific Title
Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery
Scientific Title:Acronym
Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery
Region
| Japan |
Condition
Condition
Patients who undergo gastroenterologic surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effect of syringe pressure wound irrigation with saline on the incidence of surgical site infection after gastroenterological surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of incisional surgical site infection within 30 days after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
intraoerative wound irrigation with 100 mL of saline, delivered using a 20ml syringe with a 20 gauge intravenous catherter, applying from at a distance of 10-15cm from the wound tissue for approximately 30 seconds.
Interventions/Control_2
intraoperative wound irrigation with 100 mL of saline without any pressure for approximately 30 seconds.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled to undergo elective surgery for esophagus, stomach, duodenum, jejunum, ileum, colorectal, pancreas, liver or biliary tract with a class II (clean-contaminated) or class III (contaminated ) surgical wound
Key exclusion criteria
1 Identification of bacterial infection in the surgical field or the use antibiotic therapy prior to the operation.
2 Open wound management for prior operation.
3 Synchronous operation for more than two targeted organs.
4 Presence of a stoma.
5 Pregnancy
6 Under 18 years old
7 Emergency surgery
8 Conditions that make the patient unsuitable for inclusion according to the judgement of non-blinded investigators.
Target sample size
1408
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Rikiyama |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
TEL
0486472111
trikiyama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Matsuzawa |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
TEL
048-647-2111
Homepage URL
matsuzawa.natsumi@jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
Tel
0486472111
s-suishin@jichi.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
| 2024 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061983
