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临床试验/NCT02510144
NCT02510144已完成不适用

Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Skin Swab and Culture With Colony Forming Units (CFUs)

研究概览

简要总结

Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.

详细描述

After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine gluconate skin cleanser. Participants will be instructed to conduct skin wash using the appropriate solution in the shower over the operative shoulder and axilla for three mornings prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific instructions will include leaving the solution on the skin for three minutes and avoiding contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient recruitment and given as a handout with the wash solution provided. A reminder phone call will occur two days before surgery to remind patients of proper procedure to improve compliance. On the day of surgery, patients be interviewed about pre-operative compliance.

On the day of surgery, two cultures will be taken in three separate sites on both shoulders (anterior, lateral, and posterior) using a detergent scrub technique, the current dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is typically performed on the skin of awake patients and causes minimal pain and skin irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a possible indicator of a more virulent strain in the literature.

The research team may take photos of the shoulder skin being swabbed. Photos will not include the facial or defining characteristics. Photos may be taken either in the clinic at time of recruitment or in the operating room when samples are being taken.

Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy. Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl peroxide. Anyone with a history of previous shoulder infection, current open skin lesions around the shoulder or the use of current anti-acne medications around the shoulder.

Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a threshold of P. Acnes is met (>1000 Colony Forming Units (CFUs)) then volunteers will be randomized to the same two groups and retested after three days of unilateral treatment. Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was finalized.

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
Triple (Participant, 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
否

入选标准

  • •Indicated for shoulder surgery

排除标准

  • •History of previous shoulder infection
  • •Allergy to Chlorhexidine or benzoyl peroxide
  • •Current use of anti-acne medicine around the shoulder
  • •Patient is pregnant or concerned about pregnancy

研究组 & 干预措施

Chlorhexidine

Active Comparator

A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)

干预措施: Skin Prep Chlorhexidine (Drug)

Benzoyl Peroxide

Experimental

A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)

干预措施: Skin Prep Benzoyl Peroxide (Drug)

结局指标

主要结局

Skin Swab and Culture With Colony Forming Units (CFUs)

时间窗: At time of surgery

Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.

次要结局

  • Surgical Site Infection That Requires Antibiotics(At one year)

研究者

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

Mohit N. Gilotra

Assistant Professor of Orthopaedics

University of Maryland, Baltimore

研究点 (1)

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