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

Objective: Preoperative antiseptic preparations are commonly used in transnasal skull-base surgery but evidence supporting their use in preventing postoperative infectious complications is lacking. This study aied to assess the efficacy of preoperative antiseptic techniques in patients undergoing endoscopic transnasal skull-base surgeries, in terms of reducing postoperative infectious complications within 30-day period.

Methods: Prospective, multicenter, single-blinded, three arms randomized controlled trial (RCT). Adult, consecutive patients undergoing endoscopic transnasal skull-base surgeries were included. We excluded patients with evidence of infection adjacent to surgical site, allergy to preparation methods, patients who underwent craniotomy during the same admission, and pediatric population. Patients were randomized to be prepped preoperatively with one of three methods: external normal saline cleaning (Arm 1), external chlorohexidine gluconate 0.05% cleaning (Arm 2), or external chlorohexidine gluconate 0.05% cleaning and intranasal gentamicin added to normal saline irrigation (Arm 3). The primary outcome measure was postoperative infectious complications within 30-day period.

Results: A total of 122 patients met the inclusion criteria. Males and females represented (52 patients) and (70 patients) of these, respectively. The mean age was 43 years (range: 16–79 years). Forty-three patients were assigned to Arm 1, 40 were assigned to Arm 2, and 39 patients assigned to Arm 3. Eight patients developed postoperative meningitis (five confirmed with +ve cultures), three of whom were in Arm 1, two in Arm 2, and three in Arm 3. Two patients developed postoperative sinusitis and they were assigned to Arm 1 and Arm 3. Two patients with postoperative meningitis died, and the rest cured with no sequalae.

Conclusion: Preoperative antiseptic techniques failed to prove superiority in one technique over the other in preventing postoperative infectious complications when comparing three techniques among patients who underwent endoscopic transnasal skull-base surgery.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
15 February 2022