Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine Gluconate | Drug | — | UNRESOLVED |
| Povidone-iodine | Drug | — | UNRESOLVED |
| Tetracycline Ointment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
- timeFrame
- Baseline (immediately preoperative)
- description
- Bacteria will be measured as colony forming unit/mL.
- measure
- Oral microbial abundance in preoperative samples measured by 16s sequencing.
- timeFrame
- Baseline (immediately preoperative)
- description
- This will be measured by the number of operational taxonomic units.
- measure
- Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by quantitative bacteriology.
- timeFrame
- During surgery before wound irrigation
- description
- Bacteria will be measured as colony forming unit/mL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available