Bone Diseases, InfectiousNCT03010293
Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy
An observational study of Bone Diseases, Infectious, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Diseases, Infectious
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 15 Feb 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: patients with pressure ulcer-related osteomyelitis
Who may be able to join
- Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a pressure ulcer who benefited from a two-stage surgical strategy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse
Lyon, 69004
About this study
Official title: Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy
Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.
- Conditions
- Bone Diseases, Infectious
- Keywords
- Antimicrobial therapy, Debridement, Osteomyelitis, Muscular flap, Pressure ulcer, Treatment failure, Vacuum-assisted closure therapy
- Medical subject headings
- Bone Diseases, Infectious, Osteomyelitis, Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
Treatment failure will include: 1) local clinical and/or microbiological relapse; and/or 2) need for additional surgery after surgical reconstruction by muscular flap; and/or 3) death of septic origin.
Measured: 2 years after antibiotic therapy disruption
Secondary outcomes (1)
Risk factor for treatment failure of a two-stage surgical strategy with prolonged antimicrobial therapy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
Risk factor for treatment failure will particularly focus on empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, optimization of local condition (including discharge, colostomy) and duration of antimicrobial therapy.
Measured: 2 years after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJun 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone Diseases, InfectiousStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, Principal investigator, Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010293
- Sponsor's protocol ID
- 69HCL16_0391
- Status last verified
- Nov 2017
- First submitted
- 2 Jan 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Triffault-Fillit C, Valour F, Guillo R, Tod M, Goutelle S, Lustig S, Fessy MH, Chidiac C, Ferry T; Lyon BJI Study Group. Prospective Cohort Study of the Tolerability of Prosthetic Joint Infection Empirical Antimicrobial Therapy. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e00163-18. doi: 10.1128/AAC.00163-18. Print 2018 Oct.
PubMed 30038037Andrianasolo J, Ferry T, Boucher F, Chateau J, Shipkov H, Daoud F, Braun E, Triffault-Fillit C, Perpoint T, Laurent F, Mojallal AA, Chidiac C, Valour F; Lyon BJI study group. Pressure ulcer-related pelvic osteomyelitis: evaluation of a two-stage surgical strategy (debridement, negative pressure therapy and flap coverage) with prolonged antimicrobial therapy. BMC Infect Dis. 2018 Apr 10;18(1):166. doi: 10.1186/s12879-018-3076-y.
PubMed 29636030
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy
- ClinicalTrials.gov ID
- NCT03010293
- Acronym / sponsor ID
- 69HCL16_0391
- Conditions
- Bone Diseases, Infectious
- Keywords
- Antimicrobial therapy, Debridement, Osteomyelitis, Muscular flap, Pressure ulcer, Treatment failure, Vacuum-assisted closure therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 5 Jan 2017 (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.
Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pressure ulcer-related osteomyelitis
Key inclusion criteria (1 listed)
- Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a pressure ulcer who benefited from a two-stage surgical strategy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
Time frame: 2 years after antibiotic therapy disruption
Treatment failure will include: 1) local clinical and/or microbiological relapse; and/or 2) need for additional surgery after surgical reconstruction by muscular flap; and/or 3) death of septic origin.
1 secondary outcome
Risk factor for treatment failure of a two-stage surgical strategy with prolonged antimicrobial therapy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
Time frame: 2 years after antibiotic therapy disruption
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 9 Nov 2017.
- Derived from this study: PubMed 30038037Triffault-Fillit C, Valour F, Guillo R, Tod M, Goutelle S, Lustig S, Fessy MH, Chidiac C, Ferry T; Lyon BJI Study Group. Prospective Cohort Study of the Tolerability of Prosthetic Joint Infection Empirical Antimicrobial Therapy. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e00163-18. doi: 10.1128/AAC.00163-18. Print 2018 Oct.
- Derived from this study: PubMed 29636030Andrianasolo J, Ferry T, Boucher F, Chateau J, Shipkov H, Daoud F, Braun E, Triffault-Fillit C, Perpoint T, Laurent F, Mojallal AA, Chidiac C, Valour F; Lyon BJI study group. Pressure ulcer-related pelvic osteomyelitis: evaluation of a two-stage surgical strategy (debridement, negative pressure therapy and flap coverage) with prolonged antimicrobial therapy. BMC Infect Dis. 2018 Apr 10;18(1):166. doi: 10.1186/s12879-018-3076-y.
- Related InfoLink provided by the sponsor.
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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.
Tristan Ferry principal investigator
Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases, Infectious, run by Hospices Civils de Lyon at 1 site 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 1 inclusion and 1 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis (time frame: 2 years after antibiotic therapy disruption). 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 NCT03010293, which also lists 2 linked publications.
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 9 Nov 2017.