UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029706 |
|---|---|
| Receipt number | R000033947 |
| Scientific Title | Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/10/25 13:22:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial
Acronym
Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial
Scientific Title
Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An evaluation of efficacy of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstructionin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to drain removal
Key secondary outcomes
Acute postoperative complication rate
Total volume of drain
Hospitalization period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction.
Interventions/Control_2
Implant-Based Breast Reconstruction without closed incision negative-pressure wound therapy.
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
Female
Key inclusion criteria
Patients are scheduled skin sparing mastectomy or nipple sparing mastectomy and immediate two-stage tissue expander/implant reconstruction.
Patients who received imformed concent and gained agreement by signature.
Key exclusion criteria
Patients who had recieved radiation therapy
before mastectomy.
Patients with hypersensitivity to silicone gel
When the doctor considers the patient is not appropriate.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Shiozaki |
Organization
Jikei University School of Medicine
Division name
Department of Plastic and reconstructive surgery
Zip code
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
mstk28@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Yoshida |
Organization
Jikei University School of Medicine
Division name
Department of Plastic and reconstructive surgery
Zip code
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
ms04-yoshida@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
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
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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | 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
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033947
