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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00534-43 | Other Identifier | RCB number |
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| Name | Class |
|---|---|
| PERSE (Prévention, Education, Recherche, Soins, Escarres) Association | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | The proposed study is a prospective, single-center pilot study lasting 28 days. Our goal is to study the temporal evolution of the bacterial communities present in the skin and digestive flora (stool) of spinal cord injured persons having one or more sacral bedsores. The study timespan can include treatment initiation, notably of antibiotics. Urinalysis for studying urinary flora will simultaneously occur. For a description of the study population, see the inclusion/exclusion criteria. Intervention: Superficial bedsore sample Intervention: 3mm tissue punch biopsy Intervention: Stool sample Intervention: Urine sample |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3mm tissue punch biopsy | Biological | Bacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28). |
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| Measure | Description | Time Frame |
|---|---|---|
| List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples | At the individual level | Baseline (day 0) |
| List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples | At the individual level | Day 28 |
| Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples | Calculated over the entire study population | baseline (day 0) |
| Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples | Calculated over the entire study population | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes. | Based on superficial and deep bedsore samples. | baseline (Day 0) |
| Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Dunyach-Remy, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Mutualiste Neurologique Propara | Montpellier | 34090 | France | |||
| Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34946833 | Derived | 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. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Bedsore superficial (swabbing) and deep (punch biopsies) samples are retained; stool and urine samples are retained. DNA extraction is aimed at describing microbial communities.
| Superficial bedsore sample | Biological | Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 & 28) |
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| Stool sample | Biological | Stool samples will be collected on days 0 and 28. |
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| Urine sample | Biological | Urine samples will be collected on days 0 and 28. |
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Based on superficial and deep bedsore samples. |
| Day 28 |
| List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples | baseline (day 0) |
| List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples | Day 28 |
| List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples | baseline (day 0) |
| List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples | day 28 |
| Nîmes |
| 30000 |
| France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine | Nîmes | 30908 | France |