Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery
Information source: Lahey Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis; Chronic Sinusitis
Intervention: Bacitracin (Drug); Nasopore sponge soaked with saline (Procedure)
Phase: N/A
Status: Withdrawn
Sponsored by: Lahey Clinic Official(s) and/or principal investigator(s):
Peter J. Catalano, M.D., Principal Investigator, Affiliation: Lahey Clinic, Inc.
Summary
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.
Clinical Details
Official title: Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).
Secondary outcome: Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects requiring Endoscopic Sinus Surgery
Exclusion Criteria:
- Pediatric subjects <18 years
Locations and Contacts
Lahey Clinic, Inc., Burlington, Massachusetts 01805, United States
Additional Information
Related publications: Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81.
Starting date: January 2009
Last updated: April 12, 2012
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