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Prophylactic Antibiotic Duration in Head and Neck Cancer Surgery (PROTECT-HN Trial)

RecruitingPhase 3Ages 18 Years - anyAllAC Camargo Cancer Center
NCT07851857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn whether giving antibiotics for 7 days after surgery, instead of the usual 24 hours, lowers the chance of wound infection in adults having major surgery for mouth or throat cancer. This includes operations that rebuild the area with tissue taken from another part of the body (free-flap reconstruction). The main question it aims to answer is: Does a 7-day course of antibiotics after surgery lower the number of patients who get a surgical wound infection within 30 days, compared with the standard 24-hour course? Other questions are: Does the longer course shorten the time spent in the intensive care unit and in the hospital? Does it lower the number of emergency room visits, hospital readmissions, and hospital costs within 30 days? Is the longer course safe, and does it cause more side effects? Researchers will compare two groups. Both groups

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📋 Eligibility rules (as published)
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
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What it tests

  • Ampicillin/Sulbactam 24-Hour Postoperative Prophylaxis
  • Ampicillin/Sulbactam 7-Day Postoperative Prophylaxis
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Where

1 site
A.C. Camargo Cancer Center
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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