Longer antibiotic prophylaxis after head and neck cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults undergoing major head and neck cancer surgery with reconstruction, researchers compare a 7-day postoperative course of ampicillin/sulbactam to the conventional 24-hour course. All participants receive the antibiotic around the time of surgery, and the study focuses on surgical wound infections within 30 days, plus potential effects on ICU and hospital stay, readmissions, and costs. Safety and side effects of the longer course are also monitored. The trial is randomized and aims to provide clearer guidance for antibiotic prophylaxis in complex head and neck reconstructions. This work addresses a gap in guidelines that may not account for reconstruction-specific risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Diagnosis of cancer of the oral cavity or pharynx
* Scheduled for major head and neck surgery (e.g., mandibulectomy, pharyngolaryngectomy, major glossectomy) and/or reconstruction with a microvascular free flap or pedicled flap
* Communication between the primary tumor site and the neck during surgery (direct exposure of the neck to oral or pharyngeal contents)
* Signed informed consent

Exclusion Criteria:

* Known allergy to ampicillin/sulbactam, penicillins, or other beta-lactam antibiotics
* Infected surgical field, or active infection needing therapeutic antibiotics at the time of surgery
* Refusal to participate

Where it's running

• A.C. Camargo Cancer Center
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Genival Barbosa de Carvalho, PhD
• Email: genival.carvalho@accamargo.org.br
• Phone: 55991447426

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.