Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intracranial Pathology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Participants will consist of 60 patients undergoing primary or revision endoscopic skull base surgery. 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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Drug: Antibiotic Irrigation, and Procedure/Surgery: Nasal Packing

Experimental group will receive nasal packing with antibiotic irrigation.

Group Type EXPERIMENTAL

Antibiotic Irrigation

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type ACTIVE_COMPARATOR

Antibiotic Irrigation

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT