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Topical Antisepsis in Head and Neck Cancer Surgery

NCT04721626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2022-02-07

No results posted yet for this study

Summary

This is a single-arm prospective trial of an intra- and postoperative topical antiseptic bundle. The study will recruit patients undergoing an open surgical resection of the upper aerodigestive tract requiring a planed vascularized reconstruction, which may be either pedicled and/or free flap. The objectives are to evaluate antimicrobial effects of a perioperative topical antiseptic bundle and to identify the source of surgical site infection as well as the rate of 30-day adverse events in head and neck cancer.

Conditions

Interventions

DRUG

Chlorhexidine Gluconate

Preoperative: The patient's dentition, or mandibular alveolus in the absence of dentition, will be brushed for two minutes with 0.12% chlorhexidine gluconate. Intraoperative: The wound will be irrigated for 60 seconds with 0.05% chlorhexidine after it is irrigated with povidone-iodine. Postoperative: Patients will swish and spit/suction 15mL 0.12% Chlorhexidine Gluconate (CHG) oral rinses for 30 seconds every six hours for two days (8 total administrations)

DRUG

Povidone-iodine

Preoperative: The oral cavity and oropharyngeal mucosa as well as the nasal vestibules will be coated with 5% povidone-iodine which will stand for at least three minutes prior to incision. Intraoperative: The wound will be irrigated for 60 seconds with 10% povidone-iodine.

DRUG

Tetracycline Ointment

Postoperative: \~10g 3% tetracycline ointment will be placed into the oral cavity to coat the dorsal tongue and any oral suture lines every six hours for two days (8 total doses).

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Joseph Zenga, MD · Medical College of Wisconsin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2021-05-28
Completion
2021-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721626 on ClinicalTrials.gov