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

Changes in Cutaneous, Digestive and Urinary 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.

Study Overview

• Status: Completed
• Conditions: Bedsore
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Centre Mutualiste Neurologique Propara
  • Nîmes, France, 30000
    • Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES
  • Nîmes Cedex 2, France, 30908
    • Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.	Based on superficial and deep bedsore samples.	baseline (Day 0)
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.	Based on superficial and deep bedsore samples.	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)
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples		day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
• Investigators: Study Director: Catherine Dunyach-Remy, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2015
• Primary Completion (ACTUAL): September 21, 2017
• Study Completion (ACTUAL): September 21, 2017

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (ESTIMATE): February 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: bacteria; colonization; bedsore; ecology
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: LOCAL/2013/CDR-01; 2014-A00534-43 (OTHER: RCB number)