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Safety Evaluation of Prophylactic Intrawound Vancomycin Administration in Surgery for Adolescent Idiopathic Scoliosis

Safety Evaluation of Prophylactic Intrawound Vancomycin Administration in Surgery for Adolescent Idiopathic Scoliosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061250011
Enrollment
20
Registered
2025-05-02
Start date
2025-06-04
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

Adolescent Idiopathic Scoliosis

Interventions

During posterior correction and fusion surgery for scoliosis, vancomycin hydrochloride powder for intravenous injection is applied directly into the surgical wound. The dosage is 1g.

Sponsors

Shinohara Kensuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.From 6 to 23 years old at the time of obtaining consent 2.body weight is 25 kg or more 3.Diagnosed with scoliosis who undergo posterior corrective fixation 4.Individuals who, after receiving a thorough explanation of this study and fully understanding its purpose, have provided written consent freely and voluntarily, either by themselves or through a legally authorized representative

Exclusion criteria

Exclusion criteria: 1.A known allergy to vancomycin 2.A preoperative serum creatinine (Cr) level of 1.2 mg/dL or higher 3.A history of vancomycin administration within 30 days from the date of surgery. 4.Deemed unsuitable as research subjects by the principal investigator or sub-investigators for any other reason

Design outcomes

Primary

MeasureTime frame
Postoperative Renal Dysfunction

Secondary

MeasureTime frame
1.Abnormally high postoperative vancomycin blood concentration 2.Adverse events other than renal dysfunction 3.Incidence of surgical site infection

Contacts

Public ContactKazutaka Yamashita

Okayama University Hospital

me424108@s.okayama-u.ac.jp+81-86-235-7273

Outcome results

None listed

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