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

NCT02055729 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2020-01-30

No results posted yet for this study

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.

Conditions

  • Bedsore

Interventions

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.

Sponsors & Collaborators

  • PERSE (Prévention, Education, Recherche, Soins, Escarres) Association

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Catherine Dunyach-Remy, PhD · Centre Hospitalier Universitaire de Nîmes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-11
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055729 on ClinicalTrials.gov