BedsoreEscaFlorNCT02055729
Changes in Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
An observational study of Bedsore, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bedsore
- What is being tested?
- 3mm tissue punch biopsy, Superficial bedsore sample and Stool sample
- How many people
- 55 participants
- Where
- 4 sitesFrance
- Study dates
- 11 May 2015to 21 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Mutualiste Neurologique Propara
Montpellier, 34090
Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES
Nîmes, 30000
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine
Nîmes, 30908
About this study
Official title: 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.
Read the 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.
- Conditions
- Bedsore
- Being tested
- 3mm tissue punch biopsy, Superficial bedsore sample, Stool sample, Urine sample
- Keywords
- bedsore, bacteria, colonization, ecology
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3mm tissue punch biopsyBiological
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 sampleBiological
Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 \& 28)
Stool sampleBiological
Stool samples will be collected on days 0 and 28.
Urine sampleBiological
Urine samples will be collected on days 0 and 28.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: 3mm tissue punch biopsy; Biological: Superficial bedsore sample; Biological: Stool sample; Biological: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
At the individual level
Measured: Baseline (day 0)
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
At the individual level
Measured: Day 28
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
Calculated over the entire study population
Measured: baseline (day 0)
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
Calculated over the entire study population
Measured: Day 28
Secondary outcomes (6)
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.
Based on superficial and deep bedsore samples.
Measured: 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.
Measured: Day 28
List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
Measured: baseline (day 0)
List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
Measured: Day 28
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
Measured: baseline (day 0)
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start11 May 2015
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BedsoreStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
- Responsible party
- Sponsor
- Investigators
- Catherine Dunyach-Remy, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055729
- Sponsor's protocol ID
- LOCAL/2013/CDR-01
- Other IDs
- 2014-A00534-43
- Acronym
- EscaFlor
- Status last verified
- Jan 2020
- First submitted
- 4 Feb 2014
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34946833
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02055729
- Acronym / sponsor ID
- EscaFlor / LOCAL/2013/CDR-01
- Conditions
- Bedsore
- Keywords
- bedsore, bacteria, colonization, ecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- PERSE (Prévention, Education, Recherche, Soins, Escarres) Association
- Study start
- 11 May 2015 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Biological: 3mm tissue punch biopsy, Biological: Superficial bedsore sample, Biological: Stool sample, Biological: Urine sampleThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3mm tissue punch biopsyBacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28). | Biological | The study population |
| Superficial bedsore sampleBacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 \& 28) | Biological | The study population |
| Stool sampleStool samples will be collected on days 0 and 28. | Biological | The study population |
| Urine sampleUrine samples will be collected on days 0 and 28. | Biological | The study population |
Primary outcome
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
Time frame: Baseline (day 0)
At the individual level
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples
Time frame: Day 28
At the individual level
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
Time frame: baseline (day 0)
Calculated over the entire study population
Percentage of pathogenic, potentially pathogenic, and commensal bacterial species in superficial and deep bedsore samples
Time frame: Day 28
Calculated over the entire study population
6 secondary outcomes
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.
Time frame: baseline (Day 0)
Classification of bacteria present according to respiratory type, gram negative/positive, shape, and resistance phenotypes.
Time frame: Day 28
List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
Time frame: baseline (day 0)
List of pathogenic, potentially pathogenic and commensal bacterial species in stool samples
Time frame: Day 28
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
Time frame: baseline (day 0)
List of pathogenic, potentially pathogenic and commensal bacterial species in urine samples
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 34946833Fayolle 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.
Related trials for Bedsore
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Dunyach-Remy, PhD study director
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bedsore, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of pathogenic, potentially pathogenic and commensal bacterial species in superficial and deep bedsore samples (time frame: Baseline (day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.