Application of rifampicin soaked vascular prosthesis to the infectious aortic aneurysm.

JRCT ID: jRCTs051180033

Registered date:29/01/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: infectious aneurysm or artificial blood vessel infection after transplantation
• Date of first enrollment: 03/07/2019
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Method
<Preparation of Impregnation Chemical Liquid>
For the sample, dissolve 100 mg of rifampicin powder with stirring in 100 ml of 0.05 M phosphate buffer. Subsequently, add 100 mg of ascorbic acid + 490 mg of sodium chloride (for injection), continue stirring and dissolving, use 0.1% rifampicin solution prepared by sterilizing with 0.2 micrometers filter. The above is prepared in the chemical section in a clean environment.
<Preparation of artificial blood vessel>
The following is done in a clean environment in the operating room. For artificial blood vessels using gelatin or collagen coating, open the package and soak the chemical solution for impregnation for about 1 hour.
<Implementation of artificial blood vessel replacement surgery>
As in ordinary surgery, remove the aneurysm or artificial blood vessel and replace with an artificial blood vessel impregnated with rifampicin. For the excised specimens, the causative fungus is searched.

Outcome(s)

Primary Outcome

Major endpoints: control of infectious symptoms at 12 weeks postoperative
Evaluate comprehensively with thermal clinical course, blood test data, CT etc image data

• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: The subjects to be studied should be patients diagnosed as infectious aneurysm or artificial blood vessel infection after artificial blood vessel transplantation.

Exclude criteria

Patients with history of allergy to rifampicin
Patients who could not obtain consent from research

Related Information

• Primary Sponsor: Oda Shinichiro