Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

Intracranial Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04946435
• Other study ID #: STUDY21040170
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Pathology

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Carl Snyderman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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