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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT02055729

Collaborator

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

Enrollment

Locations

28.4

Actual Duration (Months)

13.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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:

To compare bacterial communities collected from superficial versus deep samples of stage 3 or 4 sacral bedsores using metagenomics and standard culturing methods.
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.
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 Design

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 :

Sep 21, 2017

Actual Study Completion Date :

Sep 21, 2017

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples [Baseline (day 0)]
At the individual level
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 [baseline (day 0)]
Calculated over the entire study population
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

Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes. [baseline (Day 0)]
Based on superficial and deep bedsore samples.
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

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