UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	BAND-AID care for early closure of wound of surgical drains: non-blinded, randomized controlled trial
Title of the study (Brief title)	How to care wound of surgical drains: non-blinded, randomized controlled trial
Region	Japan

Condition
Condition	Patients with surgical drains longer than 2 days after urological surgery
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness of adhesive bandages with small gauze as a dressing material for wound of surgical drains: comparison with gauze dressing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Days to heal epidermis
Key secondary outcomes	Infection rate Days to heal dermis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Dressing of drain wound by band-aid plus gauze
Interventions/Control_2	Dressing of drain wound by gauze
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with urologic surgery for retroperitoneum organs Patients who agreed with this clinical trial
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	Hidetoshi Akita
Organization	Anjo Kosei Hospital
Division name	Department of Urology
Address	28 HigashiHirokute, Anjo-cho, Anjo, Japan
TEL	0566-75-2111
Email	fqpfb961@gmail.com

Public contact
Name of contact person	Yoshinobu Moritoki
Organization	Anjo Kosei Hospital
Division name	Department of Urology
Address	28 HigashiHirokute, Anjo-cho, Anjo, Aichi, Japan
TEL	0566-75-2111
Homepage URL
Email	moriji314@gmail.com

Sponsor
Institute	Anjo Kosei Hospital
Institute
Department

Funding Source
Organization	Anjo Kosei Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	R18-031
Org. issuing International ID_1	Anjo Kosei Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 03 Day
Anticipated trial start date	2018 Year 11 Month 20 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	2018 Year 11 Month 18 Day
Last modified on	2018 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039822