Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

NCT ID: NCT01222832

Last Updated: 2017-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Same as above

Conditions

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Paranasal Sinus Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bacitracin

Nasopore sponge soaked in Bacitracin, no oral antibiotics

Group Type EXPERIMENTAL

Bacitracin

Intervention Type DRUG

Bacitracin soaked nasopore sponge

Saline

Nasopore sponge soaked in saline, routine oral antibiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bacitracin

Bacitracin soaked nasopore sponge

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Peter Catalano

Chief of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Catalano, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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00534

Identifier Type: -

Identifier Source: org_study_id

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