Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Steward St. Elizabeth's Medical Center of Boston, Inc.

Status and phase: Completed; Phase 2

Conditions: Paranasal Sinus Disease

Treatments: Drug: Bacitracin

Study type: Interventional

Funder types: Other

Identifiers

NCT01222832

00534

Details and patient eligibility

About

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.

Full description

Same as above

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Bacitracin

Experimental group

Description:

Nasopore sponge soaked in Bacitracin, no oral antibiotics

Treatment:

Drug: Bacitracin

Saline

No Intervention group

Description:

Nasopore sponge soaked in saline, routine oral antibiotics