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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008747
Receipt No. R000010273
Scientific Title The efficasy of negative pressure wound therapy in the manegement of postoperative fistula in head and neck cancer surgery.
Date of disclosure of the study information 2012/09/01
Last modified on 2013/03/21

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Basic information
Public title The efficasy of negative pressure wound therapy in the manegement of postoperative fistula in head and neck cancer surgery.
Acronym Negative pressure wound therapy in the management of postoperative fistula in head and neck cancer surgery.
Scientific Title The efficasy of negative pressure wound therapy in the manegement of postoperative fistula in head and neck cancer surgery.
Scientific Title:Acronym Negative pressure wound therapy in the management of postoperative fistula in head and neck cancer surgery.
Region
Japan

Condition
Condition Head and neck cancer.
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of negative pressure wound therapy for postoperative cutaneous fistula and skin defect in head and neck cancer surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The efficacy of wound healing.
Evasion of surgical treatment.
Duratation of stay in hospital.
Adverce events.
Key secondary outcomes Number of times of local treatment.
Presence of tumor recurrence.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Device:V.A.C therapy system
Topical
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient age 20 years and above.
2. Patients with postoperative cutaneous fistula and skin defect in head and neck cancer surgery who treat spontaneous remission with standard treatment so far.
3. Patients who need reconstruction with flap or skin-grafting in surgical treatment.
4. Patients who were provided written informed consent.

Key exclusion criteria 1. Pregnancy or lactating women or women with suspected pregnancy.
2. Patients who have potential for severe complication with this teatment.
3. Patient judged by the investigator to be unfit to be enrolled into the study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junkichi Yokoyam
Organization Juntendo university school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address 3-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo university school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL
Homepage URL
Email rinri@juntendo.ac.jp

Sponsor
Institute Juntendo university school of medicine
Institute
Department

Funding Source
Organization Health and Labor Science Reserch Grant for Clinical Cancer Reserch
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 21 Day
Last modified on
2013 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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