3mm tissue punch biopsy
BiologicalBacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28).
NCT Number: NCT02055729
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.
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Notify Me18 year and older
All sexes
Observational
Centre Mutualiste Neurologique Propara, Montpellier, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28).
Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 & 28)
Stool samples will be collected on days 0 and 28.
Urine samples will be collected on days 0 and 28.
Time frame: Baseline (day 0)
At the individual level
Time frame: Day 28
At the individual level
Time frame: baseline (day 0)
Calculated over the entire study population
Time frame: Day 28
Calculated over the entire study population
Time frame: baseline (Day 0)
Based on superficial and deep bedsore samples.
Time frame: Day 28
Based on superficial and deep bedsore samples.
Time frame: baseline (day 0)
Time frame: Day 28
Time frame: baseline (day 0)
Time frame: day 28
Centre Hospitalier Universitaire de Nīmes
Other
Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
Acronym: EscaFlor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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