UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002873
Receipt number R000003509
Scientific Title A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers
Date of disclosure of the study information 2009/12/10
Last modified on 2009/12/10 22:55:07

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Basic information

Public title

A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers

Acronym

A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers

Scientific Title

A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers

Scientific Title:Acronym

A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers

Region

Japan


Condition

Condition

Esophageal disease, Gastric disease, Colon disease

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A randomized comparison between dermal suture with synthetic absorbable sutures and skinstaplers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Degree of wound pain

Key secondary outcomes

Occurrence rate of SSI


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

suture with synthetic absorbable sutures or skinstaplers

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient of Esophagseal disease, Gastric disease, or Colon disease

Key exclusion criteria

a extra-resional dissection
b emergency
c laparoscopic operation
d pneumonia, peritonisis, ileus, perforation or intraabdominal infection
e bleeding, disorder of wound healing

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Naomoto

Organization

Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

Division name

Department of Gastroenterological Surgery, Transplant and Surgical Oncology

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558, Japan

TEL

086-235-7255

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

Division name

Department of Gastroenterological Surgery, Transplant and Surgical Oncology

Zip code


Address


TEL

086-235-7255

Homepage URL


Email



Sponsor or person

Institute

Department of Gastroenterological Surgery, Transplant and Surgical Oncology
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

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 10 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

Enrolling by invitation

Date of protocol fixation

2009 Year 12 Month 01 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 10 Day

Last modified on

2009 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name