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

NCT02055729 | Completed

• 2 other identifiers: LOCAL/2013/CDR-012014-A00534-43
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 4

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.

Conditions

Bedsore

Keywords

bedsore; bacteria; colonization; ecology

Outcome Measures

Primary Outcomes (4)

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

  At the individual level

  Baseline (day 0)

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

  At the individual level

  Day 28

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

  Calculated over the entire study population

  baseline (day 0)

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

  Calculated over the entire study population

  Day 28

Secondary Outcomes (6)

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

  baseline (Day 0)

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

  Day 28

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

  baseline (day 0)

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

  Day 28

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

  baseline (day 0)

Study Arms (1)

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; Biological: Superficial bedsore sample; Biological: Stool sample; Biological: Urine sample

Interventions

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).

The study population

Superficial bedsore sample BIOLOGICAL

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

The study population

Stool sample BIOLOGICAL

Stool samples will be collected on days 0 and 28.

The study population

Urine sample BIOLOGICAL

Urine samples will be collected on days 0 and 28.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in another study, or has participated in another study in the last 3 months
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• PERSE (Prévention, Education, Recherche, Soins, Escarres) Association: collaborator

Study Sites (4)

Centre Mutualiste Neurologique Propara

Montpellier, 34090, France

Location

Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES

Nîmes, 30000, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

Nîmes, 30908, France

Location

Related Publications (1)

• Fayolle M, Morsli M, Gelis A, Chateauraynaud M, Yahiaoui-Martinez A, Sotto A, Lavigne JP, Dunyach-Remy C. The Persistence of Staphylococcus aureus in Pressure Ulcers: A Colonising Role. Genes (Basel). 2021 Nov 25;12(12):1883. doi: 10.3390/genes12121883.

  PMID: 34946833 DERIVED

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.

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Catherine Dunyach-Remy, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: May 11, 2015
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

FR (4)