UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002890
Receipt number R000003524
Scientific Title Efficacy of early debridement of burn blister at early phase of second degree burn
Date of disclosure of the study information 2009/12/14
Last modified on 2012/06/14 17:57:05

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Basic information

Public title

Efficacy of early debridement of burn blister at early phase of second degree burn

Acronym

Efficacy of early debridement of burn blister at early phase of second degree burn

Scientific Title

Efficacy of early debridement of burn blister at early phase of second degree burn

Scientific Title:Acronym

Efficacy of early debridement of burn blister at early phase of second degree burn

Region

Japan


Condition

Condition

burn

Classification by specialty

Dermatology Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effectiveness of early debridement
of burn blister to the early phase of second degree burn is examined.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cytokines and growth factors et al in the discharg of burn wound
Time to wound healing

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Maneuver

Interventions/Control_1

debridement of burn blister

Interventions/Control_2

without debridement of burn blister

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

second degree burn with blister wihtin 72 hr of injury

Key exclusion criteria

Patients with heparin or immune-suppressing drug.
patients with diabetes.
infected wound.
Other that are considered inappropriate to condcut this trial.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyomi Mihara

Organization

Nagasaki hospital

Division name

Dermatolory

Zip code


Address

1-11-12, Misasamachi, Hiroshima-city, Hiroshima, 733-0003, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nagasaki hospital

Division name

Dermatolory

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Nagasaki hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 12 Month 14 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

Terminated

Date of protocol fixation

2009 Year 11 Month 14 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 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

2009 Year 12 Month 14 Day

Last modified on

2012 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name