UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between negative pressure fixation and film dressing in wound management after tissue expansion. A prospective, open-label, randomized, single-center study.
Title of the study (Brief title)	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	Takeshi Nagata
Organization	Hamamatsu University school of medicine
Division name	Plastic and reconstructive surgery
Address	1-20-1,handayama,higasi-ku,Hamamatsu-shi,Shizuoka
TEL	053-435-2502
Email	nagatake@hama-med.ac.jp

Public contact
Name of contact person	Takeshi Nagata
Organization	Hamamatsu University school of medicine
Division name	Plastic and reconstructive surgery
Address	1-20-1,handayama,higasi-ku,Hamamatsu-shi,Shizuoka
TEL	053-435-2502
Homepage URL
Email	nagatake@hama-med.ac.jp

Sponsor
Institute	Plastic and reconstructive surgery, Hamamatsu university school of medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016785