Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

Carl Snyderman

Status and phase: Withdrawn; Phase 1

Conditions: Intracranial Pathology

Treatments: Combination Product: Antibiotic Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04946435

STUDY21040170

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

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

Experimental group

Description:

Experimental group will receive nasal packing with antibiotic irrigation.

Treatment:

Combination Product: Antibiotic Irrigation

Procedure/Surgery: Nasal Packing

Active Comparator group

Description:

Patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group.

Treatment:

Combination Product: Antibiotic Irrigation