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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00705354
Other study ID # 2007-119
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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