UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014424 |
|---|---|
| Receipt number | R000016785 |
| Scientific Title | Comparison between negative pressure fixation and film dressing in wound management after tissue expansion. A prospective, open-label, randomized, single-center study. |
| Date of disclosure of the study information | 2014/07/03 |
| Last modified on | 2017/07/03 14:39:28 |
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Basic information
Public title
Comparison between negative pressure fixation and film dressing in wound management after tissue expansion.
A prospective, open-label, randomized, single-center study.
Acronym
Comparison between negative pressure fixation and film dressing in wound management
Scientific Title
Comparison between negative pressure fixation and film dressing in wound management after tissue expansion.
A prospective, open-label, randomized, single-center study.
Scientific Title:Acronym
Comparison between negative pressure fixation and film dressing in wound management
Region
| Japan |
Condition
Condition
Patients who wish to breast reconstruction
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparing the cosmetic efficacy of NPF with FD by use of half side test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
VAS score
Key secondary outcomes
The area of the scar
Questionnaire survey
histology
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Each form of NPF and FD is used to a half of sutured wound.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
The patients that undergo tissue expander insertion surgery at the same time as the mastectomy.
Patients that gave voluntary consent to participate in this study.
The patients (aged from 18 to 65 years old) were eligible for participation.
Key exclusion criteria
1.Patients that do not give consent
2.Patients that have been subjected to the post-operative irradiation
3.Patients with adverse reaction to adhesive skin patch
4.Patients that suffer from the local infection or wound dehiscence at the study initiation
5.Patients that underwent replacement of the implant within six months after the first surgery
6.Patients that the doctor judged ineligible for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagata |
Organization
Hamamatsu University school of medicine
Division name
Plastic and reconstructive surgery
Zip code
Address
1-20-1,handayama,higasi-ku,Hamamatsu-shi,Shizuoka
TEL
053-435-2502
nagatake@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagata |
Organization
Hamamatsu University school of medicine
Division name
Plastic and reconstructive surgery
Zip code
Address
1-20-1,handayama,higasi-ku,Hamamatsu-shi,Shizuoka
TEL
053-435-2502
Homepage URL
nagatake@hama-med.ac.jp
Sponsor or person
Institute
Plastic and reconstructive surgery, Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
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
浜松医科大学医学部付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
| 2014 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016785
