Clinical trial NCT04946435: Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS
Official title: Evaluating the Effect of Prophylactic Topical Antibiotic Irrigation on Nasal Packing Colonization Following Endoscopic Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Intracranial Pathology
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Can prophylactic topical antibiotics alter the colonization of nasal packing following endoscopic skull base surgery
timeFrame: 1 year
measure: Can prophylactic topical antibiotics alter the bacterial load of nasal packing following endoscopic skull base surgery
timeFrame: 1 year
measure: Which bacteria colonize nasal packing following endoscopic skull base surgery
timeFrame: 1 year
Secondary outcomes:
measure: Does endoscopic skull base surgery later the nasal flora
timeFrame: 1 year
Other outcomes:
measure: Does nasal packing colonization correlate with causative organisms
timeFrame: 1 year
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Carl Snyderman
role: PRINCIPAL_INVESTIGATOR
References: