Clinical trial NCT02055729: Changes in Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
Official title: Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bedsore
Keywords: bedsore
bacteria
colonization
ecology
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
First posted: 2014-02-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients hospitalized in the Propara neurological rehabilitation (Montpellier, France) having at least one stage 3 or 4 bedsore in the pelvic region.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
timeFrame: Baseline (day 0)
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
timeFrame: Day 28
measure: Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
timeFrame: baseline (day 0)
measure: Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
timeFrame: Day 28
Secondary outcomes:
measure: Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.
timeFrame: baseline (Day 0)
measure: Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.
timeFrame: Day 28
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
timeFrame: baseline (day 0)
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
timeFrame: Day 28
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
timeFrame: baseline (day 0)
measure: List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
timeFrame: day 28
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Mutualiste Neurologique Propara
city: Nîmes Cedex 2
country: France
facility: Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes
country: France
facility: Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Catherine Dunyach-Remy, PhD
role: STUDY_DIRECTOR
References:
citation: Fayolle M, Morsli M, Gelis A, Chateauraynaud M, Yahiaoui-Martinez A, Sotto A, Lavigne JP, Dunyach-Remy C. The Persistence of Staphylococcus aureus in Pressure Ulcers: A Colonising Role. Genes (Basel). 2021 Nov 25;12(12):1883. doi: 10.3390/genes12121883.