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

NCT06672471 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-12-13

No results posted yet for this study

Summary

The "Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery" (PEACH) trial is a study designed to assess the necessity of post-operative antibiotics for preventing surgical site infections (SSIs) in clean-contaminated head and neck surgeries. Recognizing the pivotal role antibiotics have played since their discovery in reducing postoperative infections, this trial aims to determine if a single perioperative antibiotic dose can effectively prevent SSIs, or if additional post-operative antibiotics are required.

This study addresses a critical issue in the context of rising antibiotic resistance by potentially limiting unnecessary antibiotic use post-surgery while ensuring patient safety. Results could inform future guidelines, optimizing antibiotic use in surgical prophylaxis and contributing to global efforts against antibiotic resistance.

Conditions

  • Head and Neck Neoplasms
  • UADT Neoplasm
  • Cancer of the Head and Neck
  • Antibiotic Resistant Infection
  • Antibiotic Side Effect

Interventions

OTHER

No Post Operative Antibiotics for intervention group

No Post Operative Antibiotics in patients going clean contaminated head and neck surgery

OTHER

Post Operative Antibiotics for one day

Control group will receive perioperative as well as post operative antibiotics for one day

Sponsors & Collaborators

  • Shaukat Khanum Memorial Cancer Hospital & Research Centre

    lead OTHER

Principal Investigators

  • Dr. Syed Raza Hussain Consultant Oro-Maxillo-Facial Surgeon, MBBS, BDS, FDSRCS (ENG,IRL) · Shaukat Khanum Memorial Cancer Hospital and Research Centre

  • Dr. Muhammad Faisal Consultant Head & Neck Surgery, BDS,FCPS,FHNS · Shaukat Khanum Memorial Cancer Hospital and Research Centre

  • Dr. Shayan Khalid Ghaloo Senior Instructor Head & Neck Surg., MBBS,FCPS · Shaukat Khanum Memorial Cancer Hospital and Research Centre

  • Dr. Muhammad Awais Kanwal, MBBS,B.Sc · Shaukat Khanum Memorial Cancer Hospital and Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672471 on ClinicalTrials.gov