UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011940 |
|---|---|
| Receipt number | R000013079 |
| Scientific Title | Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery |
| Date of disclosure of the study information | 2013/10/03 |
| Last modified on | 2016/04/18 11:44:54 |
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Basic information
Public title
Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery
Acronym
Subcuticular Suture and Subcutaneous drainage for hepatobiliary pancreatic surgery
Scientific Title
Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery
Scientific Title:Acronym
Subcuticular Suture and Subcutaneous drainage for hepatobiliary pancreatic surgery
Region
| Japan |
Condition
Condition
Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease, donor of living donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive efficacy of Subcuticular Suture and subcutaneous drainage for surgical
site infection after hepatobiliary pancreatic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of incisional surgical site infection
Key secondary outcomes
Rate of wound complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Placement of subcutaneous suction drainage and suturing of wound with interrupted subcuticular suture with 3-0 monofilament material
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) Hepatobiliary pancreatic surgery, donation of living donor liver transplantation
2) Open surgery case by revers T character incision or reverse L character incision
3)4,000/mm3=<WBC<12,000 /mm3
Neu>=2,000 / mm3
Hb>=9.0 g/dL
Plt>=100,000 / mm3
T.Bil=<1.5 mg/dL
AST=<100 IU/L
ALT=<100 IU/L
Creatinin=<1.2 mg/dL
Albumin>=2.8 g/dL
4) Written informed consent.
Key exclusion criteria
1) Recipient
2) Emergency
3) Laparoscopic surgery
4) Re-laparotomy
5) Severe infections
6) Bleeding tendency or coagulation disorders
7) Uncontrolled diabetes mellitus
8) Psychic disorder
9) Severe heart or lung diseases
10) Continuous use of steroids
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Osaka University
Division name
Gastroentrological Surgery
Zip code
Address
2-2 Yamadaoka Suita, Osaka, Japan
TEL
06-6879-3251
hnagano@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maeda Sakae |
Organization
Osaka university
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
smaeda@geusrg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Gastroenterological Surgery
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
13092
Org. issuing International ID_1
Clinical Trial Center of Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013079
