UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008747
Receipt number 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 22:43:41

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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 or person

Institute

Juntendo university school of medicine

Institute

Department

Personal name



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

Value
https://center6.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