A Randomized, Placebo Controlled Trial of the Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary end point is absence of infection after 1 month follow-up.
研究概览
简要总结
The incidence of surgical site infection (SSI) infection in clean dermatologic surgery is very low, between 1-3%. Studies have demonstrated a much higher infection rate in skin excision surgeries in the lower limbs, up to 10% in most studies, and even 35.7% infection rate in a recent study from Australia.
To our knowledge, there are no clinical trials demonstrating the efficacy of prophylactic antibiotic given prior to skin lesion excision from the lower limbs.
详细描述
The majority of skin cancers are treated by surgical excision which is being performed in outpatient and primary care settings.
Surgical site infection (SSI) is one of the few complications of this relatively minor surgery. These infections often require antibiotics and repeat consultations to assess wound healing. Moreover, they can potentially lead to significant bacteremic complications and impair cosmetic outcome.
The incidence of surgical site infection (SSI), bacterial endocarditis, and joint prosthesis infection in clean dermatologic surgery is very low. This is reflected in skin lesion excisions, with a rate of between 1% and 3% in most studies.
Indiscriminate use of antibacterials is causing multidrug-resistant bacteria to emerge. Furthermore, antibacterials can cause anaphylactic reactions and even death in rare cases. There are also known interactions between several medications taken long term for underlying health problems and antibacterials.[ Therefore the routine use of antibiotics is not recommended. Despite this, medical practitioners vary greatly in their use of antibacterial prophylaxis and frequently overprescribe antibacterials for the prevention of SSI, bacterial endocarditis, and prosthesis infection.
Overall, rates of wound infection in cutaneous surgery are generally very low in clean wounds, with 1-3% quoted in most studies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting for skin excision from the thigh, shin or foot, in the Rambam medical center
排除标准
- •Younger than 18 years old.
- •Not capable of providing informed consent.
- •Declined to participate.
- •Currently taking antibiotics.
- •Surgeon feels they are clinically indicated for antibiotic treatment following excision.
- •Lesions considered as contaminated/ infected prior to surgery.
- •Excision not utilizing primary closure or skin graft.
- •Patient unable to return for suture removal.
研究组 & 干预措施
prophylactic antibiotic
Each active arm patient will be given the tested drug on admission, 30-60 minutes before the surgery, by the nurses.
2 g dose of cephalexin (or Clindamycin 600 mg for patients suffering from allergy) will be given once, orally, 30-60 minutes prior to skin lesion excision
干预措施: Cephalexin (Drug)
placebo oral capsule
Each placebo arm patient will be given the placebo drug on admission, 30-60 minutes before the surgery, by the nurses
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
The primary end point is absence of infection after 1 month follow-up.
时间窗: 1-2 years
Wounds will be assessed for infection by the doctor at the time of removal of sutures, or sooner if the patient had complaints about the wound. The definition of SSI and its classification to superficial or deep will be based on the presence of any of the following criteria that were adapted from the Centre for Disease Control and Prevention (CDC) definition for superficial SSI \[42\]. The primary outcome will consist of any SSI, superficial or deep.
次要结局
未报告次要终点