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Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery
This study is currently recruiting participants.
Verified by Lahey Clinic, February 2009
First Received: June 24, 2008   Last Updated: February 17, 2009   History of Changes
Sponsored by: Lahey Clinic
Information provided by: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00705354
  Purpose

This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.


Condition Intervention
Sinusitis
Chronic Sinusitis
Drug: Bacitracin
Procedure: Nasopore sponge soaked with saline

MedlinePlus related topics: Antibiotics Endoscopy Sinusitis Surgery
Drug Information available for: Bacitracin Bacitracin zinc
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes). [ Time Frame: Post surgical evaluations at 2/3 weeks and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue [ Time Frame: Evaluated at 2/3 weeks and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Control group undergoing standard ESS will have a saline soaked Nasopore sponge placed during surgery and will receive routine oral antibiotics post-operatively
Procedure: Nasopore sponge soaked with saline
Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
2: Experimental
Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively
Drug: Bacitracin
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics

Detailed Description:

Sinusitis affects 37 million people each year making it one of the most common health problems in the United States. It has a large impact in direct healthcare expenditures, significant loss of workplace productivity and a greater impact on quality of life than diabetes or congestive heart failure. The most frequently used treatments are medications and/or Functional Endoscopic Sinus Surgery(FESS). 100 subjects undergoing ESS will participate, randomized into two groups, treatment and control. All subjects will have a Nasopore sponge placed into the middle meatus of the nose at the end of the procedure(The sponge is FDA approved and commonly used. Subjects in the treatment group will receive a Nasopore sponge soaked in Bacitracin solution.

These subjects will not receive oral antibiotics post-operatively. The control group subjects will have a saline soaked Nasopore sponge laced during surgery and will receive routine oral antibiotics post-operatively. The hypothesis is that subjects who receive the antibiotic soaked nasal sponge in lieu of saline soaked nasal sponge will have infection rates comparable to those who receive systemic antibiotics, but because they will not receive systemic antibiotics, the treated group will have fewer side effects and the cost to treat them will be less.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects requiring Endoscopic Sinus Surgery

Exclusion Criteria:

  • Pediatric subjects <18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705354

Contacts
Contact: Peter J. Catalano, M.D. 781-744-8450 Peter.J.Catalano@Lahey.org
Contact: Joanne Bilmazes 781-744-5088 Joanne.Bilmazes@Lahey.org

Locations
United States, Massachusetts
Lahey Clinic, Inc. Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Joanne Bilmazes     781-744-5088     Joanne.Bilmazes@Lahey.org    
Principal Investigator: Peter J. Catalano, M.D.            
Sub-Investigator: Tamara Rimash, M.D.            
Sub-Investigator: Shridhar Ventrapragada, M.D.            
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Peter J. Catalano, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic, Inc. ( Peter J. Catalano, M.D. )
Study ID Numbers: 2007-119
Study First Received: June 24, 2008
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00705354     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Sinusitis
Chronic Sinusitis
Nasal Surgery
Functional Endoscopic Sinus Surgery (FESS)
Enoscopic Sinus Surgery (ESS)

Study placed in the following topic categories:
Anti-Infective Agents, Local
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Chronic Disease
Bacitracin
Sinusitis

Additional relevant MeSH terms:
Anti-Infective Agents
Disease Attributes
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Sinusitis
Bacitracin
Pharmacologic Actions
Nose Diseases
Anti-Bacterial Agents
Anti-Infective Agents, Local
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Chronic Disease

ClinicalTrials.gov processed this record on May 06, 2009