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

Bedsore Clinical Trial

— EscaFlor  

Official title:

Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055729
• Other study ID #: LOCAL/2013/CDR-01
• Secondary ID: 2014-A00534-43
• Status: Completed
• Start date: May 11, 2015
• Est. completion date: September 21, 2017

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bedsore
• Pressure Ulcer

Intervention

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).
• Superficial bedsore sample
Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 & 28)
• Stool sample
Stool samples will be collected on days 0 and 28.
• Urine sample
Urine samples will be collected on days 0 and 28.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	PERSE (Prévention, Education, Recherche, Soins, Escarres) Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples	At the individual level	Baseline (day 0)
Primary	List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples	At the individual level	Day 28
Primary	Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples	Calculated over the entire study population	baseline (day 0)
Primary	Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples	Calculated over the entire study population	Day 28
Secondary	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)
Secondary	Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.	Based on superficial and deep bedsore samples.	Day 28
Secondary	List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples		baseline (day 0)
Secondary	List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples		Day 28
Secondary	List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples		baseline (day 0)
Secondary	List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples		day 28