UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of negative pressure wound therapy for perineal wound after abdonimo-perineal resection.
Title of the study (Brief title)	Efficacy and safety of negative pressure wound therapy after abdonimo-perineal resection.
Region	Japan

Condition
Condition	Infalmmatory Bowel disease
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Perineal wound infection after abdomino-perineal resection has high incidence, especially in inflammatory bowel disease. The aim of this study is to evaluate the efficacy and safety of negative pressure wound therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence of wound infection during 30 post operative days..
Key secondary outcomes	Duration for complete wound healing. Safety(Post-operative adverse events)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	3 weeks of negative pressure wound therapy after surgery.
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who were treated with abdomono-perineal resection.
Key exclusion criteria	Patients with out consent.
Target sample size	15

Research contact person
Name of lead principal investigator	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Inflammatory Bowel Disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo,Japan
TEL	0798-45-6371
Email	motoi.uchino@nifty.ne.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Inflammatory Bowel Disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo,Japan
TEL	0798-45-6371
Homepage URL
Email	motoi.uchino@nifty.ne.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	兵庫医科大学（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 29 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 24 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027363