Topical Antisepsis in Head and Neck Cancer Surgery

NCT ID: NCT04721626

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2021-10-04

Brief 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.

Detailed Description

The study design is a single-arm prospective trial. It will investigate the microbial effects of topical antisepsis on upper aerodigestive tract and reconstructive surgery in head and neck cancer patients. The primary hypothesis is that topical antisepsis will significantly decrease oral bacterial load and the presence of pathogenic organisms. Secondary outcomes will include identification of the source of the infectious bacterial organisms, surgical and non-surgical site infections, serious topical antisepsis-related complications, serious adverse events, and hospital revisits. The study populations will include head and neck cancer patients age 18 or greater undergoing head and neck reconstructive surgery in which there is a communication between the upper aerodigestive tract and the cervical skin which requires a planned vascularized reconstruction, either a regional pedicled flap or a free tissue transfer. The accrual goal will be 25 patients. Data collection will occur in both the inpatient and outpatient settings. Patients will be enrolled during their preoperative clinic visit. Each patient will be followed for study outcomes until 30 days postoperatively.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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)

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Peridex; Iodopovidone; Adoxa CK; Adoxa TT; Amzeeq; Cleeravue-M; Zilxi

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older.

2. Planned to undergo an open surgical procedure requiring a communication between the upper aerodigestive tract and cervical skin with a planned vascularized reconstruction, which may be either a regional pedicled and/or free flap.

3. Subsites reconstructed must include at least one of the following: oral cavity, oropharynx, larynx, hypopharynx, and/or cervical esophagus.

4. Eligible patients must be undergoing surgery related to treatment for head and neck cancer. This includes immediate reconstruction after tumor ablation as well as reconstruction for delayed cancer-related indications including radionecrosis or improvement in functional outcomes after head and neck cancer treatment.

5. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria

1. True allergy to any study-related medications

2. Active infection at the time of surgery

3. Pregnancy or actively breastfeeding mothers. Female subjects who are both lactating and breastfeeding or of childbearing potential who have a positive serum test during screening.

4. Patients incarcerated in state or federal penitentiaries

5. Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Joseph Zenga

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Zenga, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00039230

Identifier Type: -

Identifier Source: org_study_id