Topical Antisepsis in Head and Neck Cancer Surgery

Medical College of Wisconsin

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Drug: Chlorhexidine Gluconate; Drug: Tetracycline Ointment; Drug: Povidone-iodine

Study type: Observational

Funder types: Other

Identifiers

NCT04721626

PRO00039230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.