Mixed-species Biofilm Composition as a Predictor of Device Longevity in Patients Using Silicone Medical Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of microbial species colonising medical device by patient
研究概览
简要总结
The purpose of this study is to determine whether the mix of microbial species isolated from biofilm-clogged voice prostheses is specific to each participant, whether the microbes are orally-derived and whether the presence of specific species is a predictor of the frequency with which patients discard devices due to malfunction. The microbes isolated from discarded devices will be used to test the antimicrobial properties of newly-developed medical silicones.
详细描述
This study has three primary objectives and one secondary objective:
Primary Objectives
- To understand variation in the composition of mixed-species biofilms on voice prostheses, both between patients and over time within patients. This will enable us to target resistance to specific microbes using chemistry-based approaches in the design of new medical silicones and develop realistic in vitro models using relevant clinical isolates with which to test them.
- To explore the association between the incidence of specific microbes in biofilms, patient factors (use of antimicrobials, antacids and dentures), and increased device-replacement frequency.
- To explore whether the colonising microbes originate from the participants's oral flora.
Secondary Objective
• To study the interactions that occur within the social group of microbes isolated from each voice prosthesis to learn a) whether these species are interdependent, b) whether they cooperate with each other in order to build biofilms and b) which species produce compounds that physically degrade medical polymers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Total larygectomy patients.
- •Must be registered at Speech and Voice Clinic, Aberdeen Royal Infirmary
排除标准
- •Under 18 years of age
结局指标
主要结局
Number of microbial species colonising medical device by patient
时间窗: 12 months
Quantification of the number of microbial species colonising medical device by patient
次要结局
- Evidence that oral carriage of a specific microbial species constitutes a risk factor for increased frequency of voice prosthesis malfunction(12 months)