NCT02055729

Changes in Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bedsore

Interventions

Type	Name	Description
BIOLOGICAL	3mm tissue punch biopsy	Bacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28).
BIOLOGICAL	Superficial bedsore sample	Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 \& 28)
BIOLOGICAL	Stool sample	Stool samples will be collected on days 0 and 28.
BIOLOGICAL	Urine sample	Urine samples will be collected on days 0 and 28.

Timeline

• Start date: 2015-05-11
• Primary completion: 2017-09-21
• Completion: 2017-09-21
• First posted: 2014-02-05
• Last updated: 2020-01-30

Locations

4 sites across 1 country: France