Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

This study has been withdrawn prior to enrollment.
(Principal Investigator left the institution requested termination.)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00705354
First received: June 24, 2008
Last updated: April 12, 2012
Last verified: April 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Names:
  • ESS
  • Endoscopic Sinus Surgery
  • Nasopore
Experimental: 2
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
Other Names:
  • ESS
  • Endoscopic Sinus Surgery
  • Nasopore
  • Anti-Bacterial

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705354

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Peter J. Catalano, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00705354     History of Changes
Other Study ID Numbers: 2007-119
Study First Received: June 24, 2008
Last Updated: April 12, 2012
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)

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

ClinicalTrials.gov processed this record on September 22, 2014