Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 250
- 主要终点
- Surgical site infection rate
研究概览
简要总结
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.
详细描述
Research rational
The use of antibiotics as prophylaxis for surgical site infection (SSI) is well based in most fields of surgery. The use of prophylactic antibiotics can reduce the rate of post-surgical infections substantially. Nonetheless, overuse of these drugs is likely to expose patients to adverse effects, increase the rate of microbial drug resistance and lead to unnecessary expenses.
In the field of dentistry there are recommendations for prevention of infective endocarditis. The use of antibiotics for SSI in the field of oral and maxillofacial surgery is not well established, with inconsistent and even contradictory recommendations.
Sinus floor lift and augmentation is a common surgical procedure in modern dentistry. It aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, prior to placement of dental implants. The procedure is performed in a per-oral approach; a mucoperiosteal flap is elevated, the lateral boney wall of the sinus is exposed and a window is cut with a surgical bur. The Schneiderian membrane (sinus periost) is separated and lifted from the bone and a bone graft material is placed into the newly created space. The graft material used can be an autograft, an allograft, a xenograft, an alloplast or a combination of these materials.
The rate of post-operative infection after a sinus lift procedure reaches 7%. An evidence based approach for antibiotic prophylaxis for this procedure does not exist. The standard of care is based on clinical experience and protocols for placing dental implants in the jaws bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.
- •Weight <150 kg.
排除标准
- •Need for prophylactic antibiotics for infective endocarditis.
- •Chronic antibiotics therapy.
- •Special populations: pregnant women, minors and legally incompetent patients.
- •Patients receiving anticoagulants.
- •Non-balanced diabetes mellitus.
- •Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.
- •Pathology of the maxillary sinus.
- •History of chronic sinusitis.
- •Patients that underwent a Caldwell-Luc procedure.
- •Patients with residual teeth roots at the planned surgical site.
- •A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.
研究组 & 干预措施
Short treatment
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
Long treatment
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
结局指标
主要结局
Surgical site infection rate
时间窗: 30 days
Deep or superficial SSI according to CDC/NHSN criteria
次要结局
- Diarrhea(30 days)
- Clostridium difficile infection(30 days)
- Adverse event rate(30 days)
研究者
michal roll
Head of Resaerch and Development Department
Tel-Aviv Sourasky Medical Center