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

Sinusitis Clinical Trial

Official title:

Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00705354
• Other study ID #: 2007-119
• Status: Withdrawn
• Phase: N/A
• First received: June 24, 2008
• Last updated: April 12, 2012
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects requiring Endoscopic Sinus Surgery

Exclusion Criteria:

• Pediatric subjects <18 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• Bacitracin
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics

Procedure:
• Nasopore sponge soaked with saline
Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc.	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).		Post surgical evaluations at 2/3 weeks and 3 months	No
Secondary	Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue		Evaluated at 2/3 weeks and 3 months	Yes