Randomized controlled trial of olanedine and isodine for surgical site infection.

JRCT ID: jRCT1051180002

Registered date:03/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Digestive surgery
• Date of first enrollment: 13/08/2018
• Target sample size: 520
• Study type: Interventional

Intervention(s)

arm A: Using Oranedine antiseptic solution 1.5% or Oranedine antiseptic solution 1.5%OR for topical medicine in surgery
arm B: Using Povidone-iodine solution 10% for topical medicine in surgery

Outcome(s)

• Primary Outcome: Occurrence ratio of SSI

Secondary Outcome

Incidence of superficial SSI, deep SSI and organ/space SSI.
Examination of bacterial culture results of SSI cases.
Subgroup analysis by operation method
Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who will be hospitalized for digestive surgery during the period of this study
(2) Patients who will received upper gastrointestinal surgery (excluding gastric / intestinal fistula surgery), lower gastrointestinal surgery (excluding stoma (closure) operation), hepatobiliary pancreatic surgery (excluding laparoscopic cholecystectomy) under general anesthesia
(3) Patients who can obtain the consent of participating
(4) Patients regardless of sex
(5) Patients who can obtain written consent from themselves for participation

Exclude criteria

(1) Patients who had occurred allergies, hypersensitivity, and serious side effects to drugs used in this study
(2) Patients with severe thyroid dysfunction
(3) Patients of gastric or intestinal fistula construction in upper gastrointestinal surgery
(4) Patients of stoma construction or closure in lower gastrointestinal surgery
(5) Patients of laparoscopic cholecystectomy in hepatobiliary pancreatic surgery

Related Information

• Primary Sponsor: Iida Hiroya
• Secondary ID(s): UMIN000032108