UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of closed incision negative-pressure wound therapy in Implant-Based Breast Reconstruction: A Randomized Controlled Trial
Title of the study (Brief title)	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	Masataka Shiozaki
Organization	Jikei University School of Medicine
Division name	Department of Plastic and reconstructive surgery
Address	3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL	03-3433-1111
Email	mstk28@gmail.com

Public contact
Name of contact person	Takuma Yoshida
Organization	Jikei University School of Medicine
Division name	Department of Plastic and reconstructive surgery
Address	3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL	03-3433-1111
Homepage URL
Email	ms04-yoshida@jikei.ac.jp

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033947