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Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children

Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children - Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027899
Enrollment
55
Registered
2017-06-25
Start date
2017-06-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who undergo surgery of catheter insertion or inguinal hernia

Interventions

An applicator of 1.5% Olamexidine gluconate is used at surgical site. The skin site exposed to 1.5% Olamexidine gluconate are inspected daily by the bed side nursse or physician to assess any adverse

Sponsors

National Center for Child Health and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Children who undergo surgery for catheter insertion or inguinal hernia from 1 to 16 years of age. (2)No abnormal appearance of the skin for surgical incision. (3)Informed concent was obtained from guardians.

Exclusion criteria

Exclusion criteria: (1)History of drug sensitivity. (2)History of shock or hypersensitivity against Chlorhexidine gluconate. (3)Patients having cutaneous disease (4)Any patients who was judged as inappropriate candidate to enroll this study

Design outcomes

Primary

MeasureTime frame
Primary outcome was determined to assess the rate of any adverse effect such as labo data, vital sign, subjective and objective symptom, erythema or irritation of the skin.

Countries

Japan

Contacts

Public ContactKyoko Hagino

National Center for Child Health and Development Division of Medical Research

hagino-k@ncchd.go.jp03-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026