Phase 2 N=226 Randomized Prevention

Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Paranasal Sinus Disease

Bottom Line

View on ClinicalTrials.gov: NCT01222832 ↗

Enrolled (actual)

226

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Rate of Infection — 113; 113 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bacitracin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Infection	113; 113	—

Summary

This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Eligibility Criteria

Inclusion Criteria

Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.

Exclusion Criteria

Age less then 18
Known sensitivity to Bacitracin
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01222832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.