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

Completed

• Conditions: Bedsore
• Interventions: Biological: 3mm tissue punch biopsy; Biological: Superficial bedsore sample; Biological: Stool sample; Biological: Urine sample

• Registration Number: NCT02055729
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Study Start: 2015-05-11
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Stool sample	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
The study population	Superficial bedsore sample	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
The study population	Urine sample	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
The study population	3mm tissue punch biopsy	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

Primary Outcome Measures

Name	Time	Method
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples	Day 28	At the individual level
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples	Day 28	Calculated over the entire study population

Secondary Outcome Measures

Name	Time	Method
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.	Day 28	Based on superficial and deep bedsore samples.
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples	day 28
List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples	Day 28

Trial Locations

Locations (4)

Centre Mutualiste Neurologique Propara; 🇫🇷 Montpellier, France

Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine; 🇫🇷 Nîmes Cedex 2, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES; 🇫🇷 Nîmes, France