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Completed

NCT Number: NCT02055729

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mutualiste Neurologique Propara, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Superficial bedsore sample

Biological

Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 & 28)

Stool sample

Biological

Stool samples will be collected on days 0 and 28.

urine sample

Biological

Urine samples will be collected on days 0 and 28.

Primary outcomes

  1. List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples

    Time frame: Baseline (day 0)

    At the individual level

  2. List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples

    Time frame: Day 28

    At the individual level

  3. Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples

    Time frame: baseline (day 0)

    Calculated over the entire study population

  4. Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples

    Time frame: Day 28

    Calculated over the entire study population

Secondary outcomes

  1. Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.

    Time frame: baseline (Day 0)

    Based on superficial and deep bedsore samples.

  2. Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.

    Time frame: Day 28

    Based on superficial and deep bedsore samples.

  3. List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples

    Time frame: baseline (day 0)

  4. List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples

    Time frame: Day 28

  5. List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples

    Time frame: baseline (day 0)

  6. List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples

    Time frame: day 28

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EscaFlor

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2014
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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