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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055729
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease Intervention/treatment
Bedsore Biological: 3mm tissue punch biopsy Biological: Superficial bedsore sample Biological: Stool sample Biological: Urine sample

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.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Group/Cohort Intervention/treatment
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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Bedsore superficial (swabbing) and deep (punch biopsies) samples are retained; stool and urine samples are retained. DNA extraction is aimed at describing microbial communities.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055729


Locations
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France
Centre Mutualiste Neurologique Propara
Montpellier, France, 34090
Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine
Nîmes Cedex 2, France, 30908
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES
Nîmes, France, 30000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
Investigators
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Study Director: Catherine Dunyach-Remy, PhD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02055729    
Other Study ID Numbers: LOCAL/2013/CDR-01
2014-A00534-43 ( Other Identifier: RCB number )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
bedsore
bacteria
colonization
ecology
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases