Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

Evaluating the Effect of Prophylactic Topical Antibiotic Irrigation on Nasal Packing Colonization Following Endoscopic Skull Base Surgery

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

Study Overview

• Status: Withdrawn
• Conditions: Intracranial Pathology
• Intervention / Treatment: Combination product: Antibiotic Irrigation

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Benita Valappil; Phone Number: 4128641744; Email: valappilb2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Antibiotic Irrigation, and Procedure/Surgery: Nasal Packing; Experimental group will receive nasal packing with antibiotic irrigation.	Combination product: Antibiotic Irrigation; The first 30 patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group. The following 30 patients will be assigned to the experimental group. Immediately following surgery, the control group will receive nasal packing alone and the experimental group will receive nasal packing with antibiotic irrigation
Active Comparator: Procedure/Surgery: Nasal Packing; Patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group.	Combination product: Antibiotic Irrigation; The first 30 patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group. The following 30 patients will be assigned to the experimental group. Immediately following surgery, the control group will receive nasal packing alone and the experimental group will receive nasal packing with antibiotic irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Can prophylactic topical antibiotics alter the colonization of nasal packing following endoscopic skull base surgery	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.	1 year
Can prophylactic topical antibiotics alter the bacterial load of nasal packing following endoscopic skull base surgery	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).	1 year
Which bacteria colonize nasal packing following endoscopic skull base surgery	The bacteria making up the colonization of nasal packing post-endoscopic skull base surgery will be identified using culture analysis.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does endoscopic skull base surgery later the nasal flora	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	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does nasal packing colonization correlate with causative organisms	The similarities or differences in bacteria colonizing nasal packings post-surgery in the study sample and causing meningitis in previous skull base patients will be investigated using culture analysis and chart review.	1 year

Collaborators and Investigators

• Sponsor: Carl Snyderman
• Investigators: Principal Investigator: Carl Snyderman, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: STUDY21040170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes