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临床试验/NCT06513182
NCT06513182已完成不适用

Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty? A Randomized Controlled Trial

University of Utah2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Positive C acnes culture

研究概览

简要总结

Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.

详细描述

Prosthetic joint infection (PJI) is a relatively uncommon but devastating complication of shoulder arthroplasty. Published rates of PJI after shoulder arthroplasty range one to ten percent. Since the advent of surgery, infection has been a constant battle. As a profession, we have made strides in preventing infection. Infection prevention started with the popularization of hand washing and preparation and draping of the sterile field in the nineteenth and twentieth centuries, with more recent advancements including pre-operative and intra-operative antimicrobial washes, antibiotic powders, and ultraviolent light exposure. Despite these advancement, PJI continues to be a problem in orthopaedic arthroplasty surgery, and we need to continue to improve our infection prevention techniques.

Risk factors for PJI in shoulder arthroplasty include revision surgery, obesity, male gender, younger age, and non-osteoarthritis indication for surgery. Unfortunately, the majority of these risk factors are non-modifiable and are difficult to mitigate short of avoiding surgery on these patients. Due to this, surgeons need to continue to find ways of preventing PJI both pre-operatively and intra-operatively. The most frequent bacteria responsible for shoulder PJI are cutibacterium acnes and s. epidermidis, causing an estimated 67 and 27 percent of shoulder PJIs respectively. C. acnes is difficult to prevent due to its prevalence in the sebaceous glands in the shoulder, neck, and upper back area. Published methods of preventing c. acnes infection include pre-operative antibiotics, skin preparation with hydrogen peroxide wash, betadine wash after skin incision, and many others. Most of these methods focus on destroying the bacterium that are present in the wound. The inherent problem is that c. acnes is symbiotic and lives in human skin, therefore attempting to destroy it is an uphill battle as it will continue to recolonize the wound through the operation.

A relatively novel method of preventing PJI has been with the use of a wound protection device. While there is some outcome data with the use of this device in hip arthroplasty, there is minimal data in regards to shoulder arthroplasty. The only peer-reviewed study of use of a flexible wound protector in shoulder arthroplasty demonstrated a decrease in c. acnes colonization in shoulder wounds after placement of a wound protector. The purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of c. acnes in primary shoulder arthroplasty.

PRELIMINARY STUDIES:

A study at the investigators institution looked at the use of a hydrogen peroxide skin preparation prior to shoulder arthroplasty surgery, and found that the standardized peroxide preparation decreased surgical wound colonization with c. acnes to 10 percent versus 35 percent in the control group. While the proposed study is different, the investigators intend to use a similar study protocol as this is a proven protocol that worked effectively within this institution.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary anatomic or reverse shoulder arthroplasty by one of three surgeons will be eligible.

排除标准

  • revision arthroplasty,
  • history of ipsilateral shoulder infection,
  • patients unable or unwilling to consent,
  • prisoners,
  • pregnant individuals,
  • mentally disabled patients,
  • employees of the University of Utah,
  • allergy to polyurethane polyester.

研究组 & 干预措施

Control - no wound protector

Other

The (control - no wound protector) will not use the protector device during the course of the surgery. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis.

干预措施: No Alexis orthopaedic protector (Other)

Wound protector

Experimental

Wound protector group will have an insertion of a wound protector after making an initial superficial approach to the shoulder. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. The wound protector will then remain in place until the end of the case during wound closure.

干预措施: Alexis orthopaedic protector (Device)

结局指标

主要结局

Positive C acnes culture

时间窗: 2-weeks

The primary outcome of the study will be percent of positive C acnes culture results.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Joyce

Principle Investigator

University of Utah

研究点 (2)

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