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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011940 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease, donor of living donor liver transplantation | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka University, Gastroenterological Surgery |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013079 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |