NCT03010293

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

January 2, 2017

Last Update Submit

November 7, 2017

Conditions

Bone Diseases, Infectious

Keywords

Antimicrobial therapyDebridementOsteomyelitisMuscular flapPressure ulcerTreatment failureVacuum-assisted closure therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    2 years after antibiotic therapy disruption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with pressure ulcer-related osteomyelitis

You may qualify if:

  • Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a pressure ulcer who benefited from a two-stage surgical strategy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (2)

  • 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.

    PMID: 30038037DERIVED

  • Andrianasolo 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.

    PMID: 29636030DERIVED

Related Links

MeSH Terms

Conditions

Bone Diseases, InfectiousOsteomyelitisPressure Ulcer

Condition Hierarchy (Ancestors)

InfectionsBone DiseasesMusculoskeletal DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tristan Ferry

    Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 5, 2017

Study Start

June 1, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

FR(1)