Topical Antisepsis in Head and Neck Cancer Surgery

A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Chlorhexidine Gluconate; Drug: Povidone-iodine; Drug: Tetracycline Ointment

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral microbial abundance in preoperative samples measured by quantitative bacteriology.	Bacteria will be measured as colony forming unit/mL.	Baseline (immediately preoperative)
Oral microbial abundance in preoperative samples measured by 16s sequencing.	This will be measured by the number of operational taxonomic units.	Baseline (immediately preoperative)
Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by quantitative bacteriology.	Bacteria will be measured as colony forming unit/mL.	During surgery before wound irrigation
Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by 16s sequencing.	This will be measured by the number of operational taxonomic units.	During surgery before wound irrigation
Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by quantitative bacteriology.	Bacteria will be measured as colony forming unit/mL.	During surgery following wound irrigation
Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by 16s sequencing.	This will be measured by the number of operational taxonomic units.	During surgery following wound irrigation
Oral microbial abundance in postoperative samples measured by quantitative bacteriology.	Bacteria will be measured as colony forming unit/mL.	Postoperative day 3.
Oral microbial abundance in postoperative samples measured by 16s sequencing.	This will be measured by the number of operational taxonomic units.	Postoperative day 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with surgical site infection	Surgical site infection diagnosis must be performed by the attending physician and occur within 30 days post-operatively. Diagnosis will include either: 1) purulent drainage from incision, 2) incision spontaneously dehisced or opened by the surgeon because of infection, 3) abscess or other evidence of infection involving a deep incision; or 4) surgical site infection diagnosis by the surgeon.	30 days
Number of subjects with 30-day hospital revisits	Defined as any unanticipated hospital readmission within 30 days of the index surgery.	Up to 30 days
Number of subjects with non-surgical site infections	An infection of the tracheobronchial tree, urinary tract, or blood, as determined by the isolation of pathogenic microorganisms from these sites in the setting of clinical signs and symptoms of infection in accordance with the International Nosocomial Infection Control Consortium (INICC) criteria. Pneumonia, clinical sepsis, and symptomatic urinary tract infection without an identified pathogenic microorganism may be diagnosed according to the INICC guidelines.	30 days
The number of subjects with serious topical antisepsis-related complications	Serious adverse event is deemed related to or probably related to the topical antiseptic agent. When topical antiseptic-related complications are suspected by the attending physician, the infectious disease service will be consulted, and a serious topical antiseptic-related complication will be diagnosed based on their recommendations.	30 days

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Joseph Zenga, MD, Medical College Of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Disinfectants; Plasma Substitutes; Blood Substitutes; Doxycycline; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate; Tetracycline
• Other Study ID Numbers: PRO00039230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No