UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004836 |
|---|---|
| Receipt number | R000005759 |
| Scientific Title | Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial. |
| Date of disclosure of the study information | 2011/01/07 |
| Last modified on | 2020/08/05 10:20:06 |
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Basic information
Public title
Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Acronym
Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Scientific Title
Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Scientific Title:Acronym
Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Region
| Japan |
Condition
Condition
Cases undergoing gastrointestinal, abdominal vascular, hepatobiliary and pancreatic open surgery.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing the hypothesis that incidence of surgical site infection in abdominal wound closure is significant less with buried subcuticular suture than skin staple
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
rate of superficial surgical site infection
Key secondary outcomes
rate of deep surgical site infection,hospitalization after surgery,hospitalization cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Abdominal wound closure with buried subcuticular suture.
Interventions/Control_2
Abdominal wound closure with skin staple.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases undergoing gastrointestinal, abdominal vascular, hepatobiliary and pancreatic open surgery.
Key exclusion criteria
laparoscopic surgery,repair of hernia,
only colostomy or ileostomy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imamura |
Organization
Tokyo Metropolitan Tama Medical center
Division name
department of surgery
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-323-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imamura |
Organization
Tokyo Metropolitan Tama Medical center
Division name
department of surgery
Zip code
Address
TEL
042-323-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
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
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
| 2011 | Year | 01 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | 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
| 2011 | Year | 01 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005759
