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NCT00915967: POWI

Prevention of Neurosurgical Wound Infections

Completed NA Results posted Last updated 30 April 2019
What this trial tests

NA trial testing Vancomycin in Surgical Wound Infections in 214 participants. Completed in 19 December 2014.

Timeline
13 May 2009
Primary endpoint
19 December 2014
19 December 2014

Quick facts

Lead sponsorOregon Health and Science University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment214
Start date13 May 2009
Primary completion19 December 2014
Estimated completion19 December 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 99, any sex, with Surgical Wound Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Infection That Requires Removal of the Neurosurgical Device Primary · Six months post-operation

The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.

GroupValue95% CI
Vancomycin97
Saline98

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vancomycin
Serious: 0/98 (0%)
Deaths: 0/98
Saline
Serious: 0/100 (0%)
Deaths: 0/100
Other adverse events (1 terms — click to expand)

ReactionSystemVancomycinSaline
InfectionSurgical and medical procedures

Data from ClinicalTrials.gov NCT00915967 adverse events section.

Sponsor's own description

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Vancomycin

Trials testing the same drug.

Other recruiting trials for Surgical Wound Infections

Currently open trials in the same condition.

Other Oregon Health and Science University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00915967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing