UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009377
Receipt number R000010952
Scientific Title To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT
Date of disclosure of the study information 2012/11/22
Last modified on 2019/05/28 10:29:59

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Basic information

Public title

To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT

Acronym

Sprinkling Vancomycin or Ampicillin Powder into Operative Field.

Scientific Title

To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT

Scientific Title:Acronym

Sprinkling Vancomycin or Ampicillin Powder into Operative Field.

Region

Japan


Condition

Condition

Patients undergoing thoracolumbar fusion surgery

Classification by specialty

Orthopedics Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Is it possible to decrease severe post surgical site severe infection by using Vancomycin powder?

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Surgical site infection (SSI) within one year after the surgery based on the international SSI definition.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Sprinkling Vancomycin Powder into Operative Field and bone tips after Thoracolumbar fusion surgery.

Interventions/Control_2

Sprinkling Ampicillin Powder into Operative Field and bone tips after Thoracolumbar fusion surgery.

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

All Patients undergoing thoracolumbar fusion surgery.

Key exclusion criteria

1. The patients with putting the drainage more than three days after the fusion surgery.
2. The patients with performing antibiotic DIV more than four days after the fusion surgery.
3. The patients with allergy for Vancomycin and Ampicillin.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mikinobu
Middle name
Last name Takeuchi

Organization

Aichi Medical University

Division name

Spine Center

Zip code

480-1195

Address

1-1, Karimata Yazako Nagakute City Aichi

TEL

0561-62-3311

Email

neuromicky@gmail.com


Public contact

Name of contact person

1st name Mikinobu
Middle name
Last name Takeuchi

Organization

Aichi Medical University

Division name

Spine Center

Zip code

480-1195

Address

1-1, Karimata Yazako Nagakute City Aichi

TEL

0561-62-3311

Homepage URL


Email

neuromicky@hotmail.com


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



Funding Source

Organization

general incorporation foundation Aikeikai

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Aichi Medical University

Address

1-1, Karimata, yazako, Nagakute City, Japan

Tel

0561-62-3311

Email

syomu@aichi-med-u.ac.jp


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

愛知医科大学病院


Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 22 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000010952&ty

Publication of results

Published


Result

URL related to results and publications

J Neurosurg Spine. 2018 Nov 1;29(5):553-559. doi: 10.3171/2018.3.SPINE171111.

Number of participants that the trial has enrolled

265

Results

The trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).

Results date posted

2019 Year 05 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The two groups did not significantly differ with respect to age, blood loss, operative time, number of fusion levels, dia- betes status, smoking habits, BMI, previous thoracic and/ or lumbar surgery, steroid use, presence of trauma, or pre- operative JOABPEQ scores, although they did differ in terms of patient sex (p = 0.04).

Participant flow

The criteria for inclusion were subjects undergoing tho- racic and/or lumbar fusion surgery. The exclusion criteria were allergies to VCM or AMP.

Adverse events

None

Outcome measures

The primary endpoint was the observation of deep or superficial SSI within 1 year of surgery.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2012 Year 10 Month 15 Day

Date of IRB

2012 Year 11 Month 22 Day

Anticipated trial start date

2012 Year 11 Month 22 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 21 Day

Last modified on

2019 Year 05 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010952


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name