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Clinical Trials/NCT04946435
NCT04946435
Withdrawn
Phase 1

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

Carl Snyderman1 site in 1 countryMarch 1, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Intracranial Pathology
Sponsor
Carl Snyderman
Locations
1
Primary Endpoint
Which bacteria colonize nasal packing following endoscopic skull base surgery
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Carl Snyderman
Responsible Party
Sponsor Investigator
Principal Investigator

Carl Snyderman

Professor

University of Pittsburgh

Eligibility Criteria

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

Outcomes

Primary Outcomes

Which bacteria colonize nasal packing following endoscopic skull base surgery

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Does endoscopic skull base surgery later the nasal flora(1 year)

Study Sites (1)

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