Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery: A Randomized Three-Arm Controlled Trial

Study Design This is a multicenter, prospective, randomized, single-blind, three-arm trial conducted at three skull base centers in Riyadh, Saudi Arabia. The null hypothesis was that infectious outcomes would not differ between the three intervention groups.

Ethics Consideration The patients provided written informed consent to participate, and the institutional review boards approved the study of the participating institutions. This study was approved by the Ethics Review Boards (E-18-3331). This study was conducted using the CONSORT guidelines.7

Population Patients were screened at neurosurgery service in three skull base centers from February 2019 to September 2021; follow-up was completed in October 2021. Eligible patients were adults with skull base pathologies scheduled for ETSBS. The exclusion criteria included pediatric patients aged <14 years, known allergy to CHG or gentamicin, evidence of infection at or adjacent to the operative site prior to surgery, open craniotomy during hospitalization, and immunosuppression. Fourteen years of age was used as the age limit as this is the age of the pediatric population in the Saudi health system.

Interventional Groups Three antiseptic preparation techniques were utilized in this study in a stepwise fashion, from minimal to maximal antisepsis: Group 1, external 0.9% NaCl nasal preparation; Group 2, external nasal preparation with antisepsis by CHG 0.05%; and Group 3, intranasal irrigation with 80 mg of gentamicin added to 1000 ml of 0.9% NaCl plus external nasal preparation with antisepsis by CHG 0.05%

Randomization Procedure Patients were randomized into blocks of three intervention groups and distributed to the participating centers. The primary surgeon was blinded to the intervention method until the day of surgery. The patients were randomized using a computer-generated list of random numbers (http://www.randomizer.org). Block randomization in three-patient blocks based on the institution was performed to ensure that approximately equal numbers of patients in each group from each site were randomized.