Clinical trial NCT00705354: Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery
Official title: Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sinusitis
Chronic Sinusitis
Keywords: Sinusitis
Chronic Sinusitis
Nasal Surgery
Functional Endoscopic Sinus Surgery (FESS)
Enoscopic Sinus Surgery (ESS)
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: Inclusion Criteria:

* Subjects requiring Endoscopic Sinus Surgery

Exclusion Criteria:

* Pediatric subjects \<18 years

Primary outcomes:
measure: The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).
timeFrame: Post surgical evaluations at 2/3 weeks and 3 months
Secondary outcomes:
measure: Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue
timeFrame: Evaluated at 2/3 weeks and 3 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: Peter J. Catalano, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/S0194-59980300469-8.