Faculty Collaboration Database

A phase 2 trial of a topical antiseptic bundle in head and neck cancer surgery: Effects on surgical site infection and the oral microbiome. EBioMedicine 2022 Jul;81:104099

Date

06/08/2022

Pubmed ID

35671624

Pubmed Central ID

PMC9168040

DOI

10.1016/j.ebiom.2022.104099

Scopus ID

2-s2.0-85131428877 (requires institutional sign-in at Scopus site)   3 Citations

Abstract

BACKGROUND: Head and neck cancer (HNC) surgery remains an important component of management but is associated with a high rate of surgical site infection (SSI). We aimed to assess the safety and efficacy of a topical mucosal antiseptic bundle in preventing SSI and evaluate microbial predictors of infection through a genomic sequencing approach.

METHODS: This study was an open-label, single-arm, single-center, phase 2 trial of a topical mucosal antiseptic bundle in patients with HNC undergoing aerodigestive tract resection and reconstruction. Patients underwent topical preparation of the oral mucosa with povidone-iodine (PI) and chlorhexidine gluconate (CHG) pre- and intra-operatively followed by oral tetracycline ointment every 6 hours for 2 days post-operatively. The primary outcome was change in bacterial bioburden at the oral surgical site. Secondary outcomes included safety, SSI, and microbial predictors of infection.

FINDINGS: Of 27 patients screened between January 8, 2021, and May 14, 2021, 26 were enrolled and 25 completed the study. There were no antiseptic-related adverse events. The topical mucosal antiseptic bundle significantly decreased oral bacterial colony-forming units from pre-operative levels (log₁₀ mean difference 4·03, 95%CI 3·13-4·;92). There were three SSI (12%) within 30 days. In correlative genomic studies, a distinct set of amplicon sequence variants in the post-operative microbiome was associated with SSI. Further, despite no instance of post-operative orocervical fistula, metagenomic sequence mapping revealed the oral cavity as the origin of the infectious organism in two of the three SSI.

INTERPRETATION: The bacterial strains which subsequently caused SSI were frequently identified in the pre-operative oral cavity. Accordingly, a topical antiseptic bundle decreased oral bacterial bioburden throughout the peri-operative period and was associated with a low rate of SSI, supporting further study of topical antisepsis in HNC surgery.

FUNDING: Alliance Oncology.

Author List

Zenga J, Atkinson S, Yen T, Massey B, Stadler M, Bruening J, Peppard W, Reuben M, Hayward M, Mesich B, Buchan B, Ledeboer N, Sanchez JL, Fraser R, Lin CW, Holtz ML, Awan M, Wong SJ, Puram SV, Salzman N

Authors

Musaddiq J. Awan MD Assistant Professor in the Radiation Oncology department at Medical College of Wisconsin
Jennifer D. Bruening MD Assistant Professor in the Otolaryngology department at Medical College of Wisconsin
Raphael Fraser PhD Assistant Professor in the Medicine department at Medical College of Wisconsin
Nathan A. Ledeboer PhD Vice Chair, Professor in the Pathology department at Medical College of Wisconsin
Chien-Wei Lin PhD Associate Professor in the Institute for Health and Equity department at Medical College of Wisconsin
Becky Massey MD Associate Professor in the Otolaryngology department at Medical College of Wisconsin
William J. Peppard PharmD Trauma/Surgical Critical Care Pharmacist in the Pharmacy department at Froedtert Hospital
Nita H. Salzman MD, PhD Director, Professor in the Pediatrics department at Medical College of Wisconsin
Michael Stadler MD Associate Dean, Chief Medical Officer, Associate P in the Medical College Physicians Administration department at Medical College of Wisconsin
Tina W F Yen MD, MS Professor in the Surgery department at Medical College of Wisconsin
Joseph Zenga MD Assistant Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Anti-Infective Agents, Local
Head and Neck Neoplasms
Humans
Microbiota
Preoperative Care
Surgical Wound Infection