Clinical trial NCT04721626: Topical Antisepsis in Head and Neck Cancer Surgery
Official title: A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligibility: Patients ≥ 18 years old planned to undergo surgical resection of the upper aerodigestive tract for a cancer-related indication and requiring reconstruction which may be either a regional pedicled and/or free tissue transfer.

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.

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.

Primary outcomes:
measure: Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
timeFrame: Baseline (immediately preoperative)
measure: Oral microbial abundance in preoperative samples measured by 16s sequencing.
timeFrame: Baseline (immediately preoperative)
measure: Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by quantitative bacteriology.
timeFrame: During surgery before wound irrigation
measure: Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by 16s sequencing.
timeFrame: During surgery before wound irrigation
measure: Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by quantitative bacteriology.
timeFrame: During surgery following wound irrigation
measure: Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by 16s sequencing.
timeFrame: During surgery following wound irrigation
measure: Oral microbial abundance in postoperative samples measured by quantitative bacteriology.
timeFrame: Postoperative day 3.
measure: Oral microbial abundance in postoperative samples measured by 16s sequencing.
timeFrame: Postoperative day 3.
Secondary outcomes:
measure: The number of subjects with surgical site infection
timeFrame: 30 days
measure: Number of subjects with 30-day hospital revisits
timeFrame: Up to 30 days
measure: Number of subjects with non-surgical site infections
timeFrame: 30 days
measure: The number of subjects with serious topical antisepsis-related complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Joseph Zenga, MD
role: PRINCIPAL_INVESTIGATOR
References: