Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Incidence of Surgical Site Infection
研究概览
简要总结
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.
详细描述
In the pre-antibiotic era, surgery was a perilous endeavour, fraught with high infection risks and grim patient outcomes. Surgeons waged a relentless battle against postoperative infections. Even routine procedures were laden with danger, leading to severe complications, high morbidity, and alarming mortality rates. The inability to curb bacterial growth in surgical wounds cast a dark shadow over the medical field, highlighting the desperate need for a revolutionary breakthrough in infection control.
The Discovery of Penicillin in 1928 by Sir Alexander Fleming marked the beginning of the Antibiotic revolution On November 28, 1942, a fire broke out at The Cocoanut Grove Nightclub, in Boston, Massachusetts, and many survivors received skin grafts which are liable to infection by Staphylococcus. Treatment with penicillin was hugely successful at the Massachusetts General Hospital. Dozens of people were rescued from near-certain death in the first public demonstration of the powers of the antibiotic, at that time the Boston Globe called it "priceless" and Time magazine dubbed it a "wonder drug. This midwifed the birth of the modern pharmaceutical industry, and nearly doubled life expectancy, from 48 years at the turn of the 20th century to 78 years in the post-World War II years.
This also provided hope for surgeons grappling with the scourge of Surgical Site Infections. Antibiotics emerged as powerful weapons in the arsenal against infectious complications, ushering in a new era of proactive infection control. For the first time, surgeons had tools to combat bacteria directly, significantly reducing postoperative complications. This newfound ability to administer antibiotics prophylactically before surgical incisions marked a profound turning point, ultimately enhancing patient safety and reshaping the surgery landscape.
Despite the remarkable achievements, the euphoria surrounding antibiotics precipitated a darker issue. The widespread and indiscriminate administration of antibiotics, sometimes in situations where they confer minimal benefit, sowed the seeds of a formidable adversary: Antibiotic Resistance. The emergence of antibiotic-resistant strains of bacteria represents an enduring challenge in modern healthcare. The overreliance on these powerful drugs inadvertently fostered the survival of resistant organisms, diminishing the effectiveness of antibiotics over time. This challenge reverberates across various medical contexts, including surgical prophylaxis, reminding us of the importance of judicious antibiotic use.
The threat of antibiotic resistance is real. Therefore, all the stakeholders must employ strategies to prevent and control antibiotic resistance to prevent an imminent post-antibiotic era, a condition that may be worse than the pre-antibiotic era.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study uses a triple blinded trial design to reduce bias, ensuring that neither the primary clinical teams, the patients, nor the post-operative assessors know the assigned treatment groups. The surgical and anesthetic teams performing the operation are blinded to group allocation, following standard care protocols without knowing if a patient receives postoperative antibiotics. Similarly, assessors who evaluate patients for surgical site infections (SSIs) during follow-up are blinded, preventing any influence on SSI assessment from knowledge of the patient's treatment group.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Patients undergoing elective Clean-contaminated head and neck surgery.
- •Patients who have provided informed consent.
- •Patients with a life expectancy of more than 6 months.
排除标准
- •Patients aged less than
- •Patients with a history of antibiotic allergies.
- •Patients with ongoing infections or those requiring preoperative antibiotics.
- •Patients with immunocompromised conditions (e.g., HIV, on immunosuppressive therapy).
- •Patients undergoing emergency surgery.
- •Patients undergoing palliative surgery.
- •Patients undergoing Clean Head and Neck Surgery.
结局指标
主要结局
Incidence of Surgical Site Infection
时间窗: 4 weeks after surgery
This will be assessed on Post Operative Physical Clinic visits and will be recorded by an assessor who will be blind to whether the patient received Post Operative antibiotic or not. SSI will be determined using a Clinical Examination and the findings will be recorded, pictures of the wound will be taken at every visit for up to four weeks to be uploaded in the patient's electronic records to be viewed later, A Standardized assessment (Looking for Spreading erythema, Localised pain, Pus or discharge from the wound, Persistent pyrexia, wound dehiscence) will be carried out by the clinician and the findings will be documented in patient electronic records in hospital information system (HIS).
次要结局
- Rate of Post Operative Complications(4 weeks after surgery)
研究者
Dr. Muhammad Awais Kanwal
Dr. Muhammad Awais Kanwal Department of Surgical Oncology
Shaukat Khanum Memorial Cancer Hospital & Research Centre
