Head and Neck CancerNCT04721626
Topical Antisepsis in Head and Neck Cancer Surgery
An observational study of Head and Neck Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Chlorhexidine Gluconate, Povidone-iodine and Tetracycline Ointment
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 4 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Chlorhexidine Gluconate, Povidone-iodine, Tetracycline Ointment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Also called Peridex
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)
Povidone-iodineDrug
Also called Iodopovidone
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.
Tetracycline OintmentDrug
Also called Adoxa CK, Adoxa TT, Amzeeq, Cleeravue-M
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
Bacteria will be measured as colony forming unit/mL.
Measured: Baseline (immediately preoperative)
Oral microbial abundance in preoperative samples measured by 16s sequencing.
This will be measured by the number of operational taxonomic units.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During surgery following wound irrigation
Oral microbial abundance in postoperative samples measured by quantitative bacteriology.
Bacteria will be measured as colony forming unit/mL.
Measured: Postoperative day 3.
Oral microbial abundance in postoperative samples measured by 16s sequencing.
This will be measured by the number of operational taxonomic units.
Measured: Postoperative day 3.
Secondary outcomes (4)
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.
Measured: 30 days
Number of subjects with 30-day hospital revisits
Defined as any unanticipated hospital readmission within 30 days of the index surgery.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start6 Jan 2021
- Primary completion28 May 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Zenga, Medical College of Wisconsin
- Investigators
- Joseph Zenga, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721626
- Sponsor's protocol ID
- PRO00039230
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome
- ClinicalTrials.gov ID
- NCT04721626
- Acronym / sponsor ID
- PRO00039230
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine GluconateAlso: PeridexPreoperative: 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) | Drug | – |
| Povidone-iodineAlso: IodopovidonePreoperative: 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. | Drug | – |
| Tetracycline OintmentAlso: Adoxa CK, Adoxa TT, Amzeeq, Cleeravue-MPostoperative: ~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). | Drug | – |
Primary outcome
Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
Time frame: Baseline (immediately preoperative)
Bacteria will be measured as colony forming unit/mL.
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.
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.
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.
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.
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.
Oral microbial abundance in postoperative samples measured by quantitative bacteriology.
Time frame: Postoperative day 3.
Bacteria will be measured as colony forming unit/mL.
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.
4 secondary outcomes
The number of subjects with surgical site infection
Time frame: 30 days
Number of subjects with 30-day hospital revisits
Time frame: Up to 30 days
Number of subjects with non-surgical site infections
Time frame: 30 days
The number of subjects with serious topical antisepsis-related complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Zenga, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbial abundance in preoperative samples measured by quantitative bacteriology. (time frame: Baseline (immediately preoperative)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.