Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of C. Acnes
研究概览
简要总结
The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:
- Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)
- Post-incision application of 3% hydrogen peroxide
- Post-incision application of 10% povidone-iodine (betadine)
- No post-incision treatment (control)
The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
详细描述
Cultures will be collected from the following sites:
- The surgical site prior to the initial incision
- The incision site after the initial incision
- The shoulder joint
- The room air
Cultures will be monitored daily for the presence of C. Acnes up to 18 days post-surgery. At postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. A password-secured database and data points will be pulled from electronic medical records. Data will be analyzed and will be utilized to come to the conclusion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Indicated and scheduled for primary shoulder arthroplasty.
- •Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
- •Ability to read and understand English
- •Age ≥18 years
- •Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)
排除标准
- •Patient with history of prior native shoulder septic arthritis or infection
- •Prior surgery of affected shoulder
- •Proximal Humerus Fracture
- •Active infection
- •Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
- •History of allergic reaction to citric acid-derived products
研究组 & 干预措施
Xperience Antimicrobial Wash
Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Xperience Antimicrobial Wash (Device)
Xperience Antimicrobial Wash
Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Bacterial Cultures (Diagnostic Test)
Xperience Antimicrobial Wash
Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Shoulder Arthroplasty (Procedure)
3% hydrogen peroxide
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Bacterial Cultures (Diagnostic Test)
Control
No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures
干预措施: Bacterial Cultures (Diagnostic Test)
Control
No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures
干预措施: Shoulder Arthroplasty (Procedure)
10% povidone-iodine
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Bacterial Cultures (Diagnostic Test)
10% povidone-iodine
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Shoulder Arthroplasty (Procedure)
10% povidone-iodine
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Povidone-Iodine (Device)
3% hydrogen peroxide
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Shoulder Arthroplasty (Procedure)
3% hydrogen peroxide
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
干预措施: Hydrogen Peroxide (Device)
结局指标
主要结局
Incidence of C. Acnes
时间窗: up to 18 days
C. Acnes cultures will be sampled from surgical site prior to the initial incision (skin culture), from the incision site after the initial incision (dermal culture), from the glenohumeral joint (glenohumeral joint culture), and from the room air (air culture). Each culture will be monitored for up to 18 days for growth of C. Acnes.
次要结局
- Number and Types of Complications(up to 1 year postop.)
- Number of Subjects that Require Postoperative Reoperations(up to 1 year postop)
研究者
Jared Mahylis
Orthopaedic Surgeon, Prinicipal Investigator
Henry Ford Health System