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

NCT00705354 | Withdrawn

• 1 other identifier: 2007-119
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis; Chronic Sinusitis

Keywords

Sinusitis; Chronic Sinusitis; Nasal Surgery; Functional Endoscopic Sinus Surgery (FESS); Enoscopic Sinus Surgery (ESS)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively

Drug: Bacitracin

Interventions

Bacitracin DRUG

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

Also known as: ESS, Endoscopic Sinus Surgery, Nasopore, Anti-Bacterial

2

Nasopore sponge soaked with saline PROCEDURE

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

Also known as: ESS, Endoscopic Sinus Surgery, Nasopore

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects requiring Endoscopic Sinus Surgery

You may not qualify if:

• Pediatric subjects \<18 years

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related 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. doi: 10.1016/S0194-59980300469-8.

  PMID: 12825040 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Interventions

Bacitracin; Anti-Bacterial Agents; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter J. Catalano, M.D.

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

US (1)