Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery: A Randomized Controlled Trial

Launched by SHAUKAT KHANUM MEMORIAL CANCER HOSPITAL & RESEARCH CENTRE · Nov 1, 2024

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ClinConnect Summary

This trial, called the PEACH study, is checking whether a single perioperative dose of antibiotics is enough to prevent surgical site infections after clean-contaminated head and neck surgery, or if patients need antibiotics for an additional day after surgery. The main question is whether post-operative antibiotics add any extra benefit. The study will compare two groups: one receives only a perioperative antibiotic dose given at the start of surgery, and the other receives that same dose plus antibiotics for one more day after surgery. Researchers will look at how often infections around the surgical site happen within four weeks, and they’ll also track other post-surgery problems. The trial uses careful blinding to keep patients, doctors, and those judging infections unbiased.

Who can join? Adults aged 18 and older who are having elective clean-contaminated head and neck surgery, can consent, and have a life expectancy of more than six months. People who are excluded include those under 18, those with antibiotic allergies, those with ongoing infections or who already need antibiotics before surgery, anyone who is immunocompromised, and those having emergency, palliative, or strictly clean head and neck procedures. If eligible, you’ll be randomly assigned to one of the two groups and receive the assigned antibiotic plan. You’ll have follow-up visits for up to four weeks to check for infections (with methods designed to avoid bias). The study is being conducted at Shaukat Khanum Memorial Cancer Hospital in Lahore, Pakistan, and data will be shared non-identifiably after the study is finished.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18 years and older.
• • 2. Patients undergoing elective Clean-contaminated head and neck surgery.
• • 3. Patients who have provided informed consent.
• • 4. Patients with a life expectancy of more than 6 months.
• Exclusion Criteria:
• • 1. Patients aged less than 18.
• • 2. Patients with a history of antibiotic allergies.
• • 3. Patients with ongoing infections or those requiring preoperative antibiotics.
• • 4. Patients with immunocompromised conditions (e.g., HIV, on immunosuppressive therapy).
• • 5. Patients undergoing emergency surgery.
• • 6. Patients undergoing palliative surgery.
• • 7. Patients undergoing Clean Head and Neck Surgery.