Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

PHASE4RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

July 1, 2017

Primary Completion Date

January 31, 2019

Study Completion Date

July 31, 2019

Conditions
AntibioticsPituitary Adenoma
Interventions
DRUG

Placebo

PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

DRUG

Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

Oral antibiotics (cefdinir \[Omnicef®\] 300 mg PO BID or trimethoprim/sulfamethoxazole \[Bactrim DS™\] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Trial Locations (1)

85013

RECRUITING

Barrow Brain and Spine, Phoenix

All Listed Sponsors
collaborator

Thomas Jefferson University

OTHER

collaborator

The Cleveland Clinic

OTHER

lead

St. Joseph's Hospital and Medical Center, Phoenix

OTHER