Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
研究概览
简要总结
The main objective of this study is to characterize the evolution (over a period of 28 days) of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic bacterial species at the intra-individual and population levels.
详细描述
The secondary objectives of this study are:
A. To compare bacterial communities collected from superficial versus deep samples of stage 3 or 4 sacral bedsores using metagenomics and standard culturing methods.
B. To characterize the evolution of digestive bacterial flora in the same patients over a period of 28 days. Changes in terms of pathogenic, potentially pathogenic and non-pathogenic will be described, as well as the appearance of resistance phenotypes.
C. To characterize the evolution of urinary bacterial flora in the same patients over a period of 28 days. Changes in terms of pathogenic, potentially pathogenic and non-pathogenic will be described, as well as the appearance of resistance phenotypes.
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
- •The patient was correctly informed about study implementation, its objectives, constraints and patient rights
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 28 days of follow-up
- •The patient has one or more pelvic pressure ulcers (bedsores)(stage 3 or 4 only). Note: Patients with bedsores of varying stage will be included for the wound corresponding to the highest stage. If the patient has multiple bedsores of the same stage, the deepest wound will be selected.
- •The patient requires a modern wound dressings (i.e. not tulle or gauze) without added bactericidal or antibiotic elements
- •The patient is hospitalized ant the Propara neurological rehabilitation center (Montpellier, France)
- •The patient has not received antibiotics in the last 14 days.
排除标准
- •The patient is participating in another study, or has participated in another study in the last 3 months
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient is already included in the present study
- •The patient has sacral pressure ulcers of only stages 1 or 2, or does not have a sacral pressure ulcer
- •Patient under curative anticoagulation
- •Patient who received antibiotics within 14 days before inclusion (however, after inclusion, the patient can be treated with antibiotics if necessary)
结局指标
主要结局
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
时间窗: Day 28
At the individual level
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
时间窗: Day 28
Calculated over the entire study population
次要结局
- Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.(Day 28)
- List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples(day 28)
- List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples(Day 28)