Topical Antisepsis in Head and Neck Cancer Surgery

NCT04721626 | Completed DMC FDA Drug

• 1 other identifier: PRO00039230
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• The number of subjects with surgical site infection

  30 days

• Number of subjects with 30-day hospital revisits

  Up to 30 days

• Number of subjects with non-surgical site infections

  30 days

• The number of subjects with serious topical antisepsis-related complications

  30 days

Interventions

Chlorhexidine Gluconate DRUG

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)

Also known as: Peridex

Povidone-iodine DRUG

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.

Also known as: Iodopovidone

Tetracycline Ointment DRUG

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).

Also known as: Adoxa CK, Adoxa TT, Amzeeq, Cleeravue-M, Zilxi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 years or older.
• 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.
• Subsites reconstructed must include at least one of the following: oral cavity, oropharynx, larynx, hypopharynx, and/or cervical esophagus.
• 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.
• 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.

You may not qualify if:

• True allergy to any study-related medications
• Active infection at the time of surgery
• 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.
• Patients incarcerated in state or federal penitentiaries
• Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Swabs will be taken of the mouth, nose, surgical site and environment. Recombinant 16s DNA (16 s) sequencing will be used to identify bacteria present at those sites.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

chlorhexidine gluconate; Povidone-Iodine; Minocycline

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Study Officials

• Joseph Zenga, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: January 6, 2021
• Primary Completion: May 28, 2021
• Study Completion: October 4, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)