TY - JOUR
T1 - A phase 2 trial of a topical antiseptic bundle in head and neck cancer surgery
T2 - Effects on surgical site infection and the oral microbiome
AU - Zenga, Joseph
AU - Atkinson, Samantha
AU - Yen, Tina
AU - Massey, Becky
AU - Stadler, Michael
AU - Bruening, Jennifer
AU - Peppard, William
AU - Reuben, Michael
AU - Hayward, Michael
AU - Mesich, Brian
AU - Buchan, Blake
AU - Ledeboer, Nathan
AU - Sanchez, Joyce L.
AU - Fraser, Raphael
AU - Lin, Chien Wei
AU - Holtz, Mary L.
AU - Awan, Musaddiq
AU - Wong, Stuart J.
AU - Puram, Sidharth V.
AU - Salzman, Nita
N1 - Funding Information:
This work was supported by the Alliance National Cancer Institute Community Oncology Research Program (NCORP) Research Base grant 7UG1CA189823 (PI: Zenga) as well as the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant Number UL1TR001436. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The authors thank the University of Wisconsin Biotechnology Center DNA Sequencing Facility for providing 16S, whole genome, and metagenomic sequencing services.
Funding Information:
This work was supported by the Alliance National Cancer Institute Community Oncology Research Program (NCORP) Research Base grant 7UG1CA189823 (PI: Zenga) as well as the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant Number UL1TR001436. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The authors thank the University of Wisconsin Biotechnology Center DNA Sequencing Facility for providing 16S, whole genome, and metagenomic sequencing services.
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
KW - Head and neck cancer surgery
KW - Surgical site infection
KW - Topical antisepsis
UR - http://www.scopus.com/inward/record.url?scp=85131428877&partnerID=8YFLogxK
U2 - 10.1016/j.ebiom.2022.104099
DO - 10.1016/j.ebiom.2022.104099
M3 - Article
C2 - 35671624
AN - SCOPUS:85131428877
SN - 2352-3964
VL - 81
JO - EBioMedicine
JF - EBioMedicine
M1 - 104099
ER -