Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

Phase 1

Withdrawn

• Conditions: Intracranial Pathology

• Registration Number: NCT04946435
• Lead Sponsor: Carl Snyderman

Brief Summary

This is an interventional study that will examine the effect of prophylactic topical antibiotics on nasal packing colonization following endoscopic skull base surgery.

Detailed Description

Following endoscopic skull base surgery (ESBS), nasal packing is used to control bleeding and to support reconstruction but can be a source for possibly infectious colonization. Antibiotic use and selection in ESBS varies largely and topical antibiotics are not routinely employed despite favorable qualities (i.e. direct delivery of high antibiotic concentrations with low adverse systemic effects). The effect of prophylactic topical antibiotics on nasal packing colonization is currently understudied. A larger study is needed to test the validity of the conclusion. Employing a larger sample size undergoing ESBS (which does not directly act on the nasal cavity), the investigators hope to amend the lack of literature evaluating the effect of prophylactic topical antibiotics on nasal packing post-ESBS. THe investigators hope to contribute to the determination of an ideal antibiotic regimen following ESBS, which may be especially beneficial for immunocompromised patients or patients at risk of post-surgery infections such as meningitis. Furthermore, the effect of ESBS on the nasal flora is largely understudied, with limited literature only reporting on the nasal flora following endoscopic sinus surgery (ESS). The investigators hope to also amend the lack of literature exploring the effects of ESBS on the nasal flora, especially long-term effects that may be examined in patients undergoing revision surgery.

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-30
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing primary or revision endoscopic skull base surgery
• Sellar or Intracranial pathology

Exclusion Criteria

• Patients with sinonasal malignancy
• Prior radiation therapy
• Concurrent sinusitis and/or nasal polyposis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Which bacteria colonize nasal packing following endoscopic skull base surgery	1 year	The bacteria making up the colonization of nasal packing post-endoscopic skull base surgery will be identified using culture analysis.
Can prophylactic topical antibiotics alter the colonization of nasal packing following endoscopic skull base surgery	1 year	The effect of prophylactic topical antibiotics on nasal packing colonization post-endoscopic skull base surgery will be measured using culture analysis. Colonization will be described as type(s) of bacteria.
Can prophylactic topical antibiotics alter the bacterial load of nasal packing following endoscopic skull base surgery	1 year	The effect of prophylactic topical antibiotics on the bacterial load of nasal packings post-endoscopic skull base surgery will be measured using culture analysis. Bacterial load will be measured in colony forming units (CFUs).

Secondary Outcome Measures

Name	Time	Method
Does endoscopic skull base surgery later the nasal flora	1 year	A secondary endpoint is to determine if ESBS alters the nasal flora. The change in nasal flora after endoscopic skull base surgery will be measured using culture analysis of pre- and post-surgery nasal swabs

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States