NCT01222832

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5 years until next milestone

Results Posted

Study results publicly available

May 31, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

October 14, 2010

Results QC Date

May 19, 2015

Last Update Submit

May 2, 2017

Conditions

Paranasal Sinus Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of Infection

    Number of participants without infections on post-op visits 90 days.

    90 days

Study Arms (2)

Bacitracin

EXPERIMENTAL

Nasopore sponge soaked in Bacitracin, no oral antibiotics

Drug: Bacitracin

Saline

NO INTERVENTION

Nasopore sponge soaked in saline, routine oral antibiotics

Interventions

BacitracinDRUG

Bacitracin soaked nasopore sponge

Bacitracin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age less then 18
  • Known sensitivity to Bacitracin
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Paranasal Sinus Diseases

Interventions

Bacitracin

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Peter catalano
Organization
SEMC
peter.catalano@steward.org
617-789-5004

Study Officials

  • Peter Catalano, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Otolaryngology

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 18, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 31, 2017

Results First Posted

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)