Topical Antisepsis in Head and Neck Cancer Surgery

• ClinicalTrials.gov Identifier: NCT04721626
• Recruitment Status: Recruiting
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Sponsor: Medical College of Wisconsin
• Information provided by (Responsible Party): Joseph Zenga, Medical College of Wisconsin

Study Description

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.

Condition or disease	Intervention/treatment
Head and Neck Cancer	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 Design

• Study Type: Observational
• Estimated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome
• Actual Study Start Date: January 6, 2021
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: February 2022

Groups and Cohorts

Intervention Details:

• Drug: 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)

  Other Name: Peridex
• 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.

  Other Name: Iodopovidone
• 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).
  Other Names:

  • Adoxa CK
  • Adoxa TT
  • Amzeeq
  • Cleeravue-M
  • Zilxi

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. The number of subjects with surgical site infection [ Time Frame: 30 days ]
   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.
2. Number of subjects with 30-day hospital revisits [ Time Frame: Up to 30 days ]
   Defined as any unanticipated hospital readmission within 30 days of the index surgery.
3. Number of subjects with non-surgical site infections [ Time Frame: 30 days ]
   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.
4. The number of subjects with serious topical antisepsis-related complications [ Time Frame: 30 days ]
   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.

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office; 414-805-8900; cccto@mcw.edu

Locations

United States, Wisconsin

Froedtert Hospital & the Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Joseph Zenga, MD 414-805-0505 jyzenga@mcw.edu

Principal Investigator: Joseph Zenga, MD

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

• Principal Investigator: Joseph Zenga, MD; Medical College of Wisconsin

More Information

• Responsible Party: Joseph Zenga, Assistant Professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT04721626
• Other Study ID Numbers: PRO00039230
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Tetracycline; Doxycycline; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents; Plasma Substitutes; Blood Substitutes; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents