Clinical trial NCT03010293: Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Diseases, Infectious
Keywords: Antimicrobial therapy
Debridement
Osteomyelitis
Muscular flap
Pressure ulcer
Treatment failure
Vacuum-assisted closure therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pressure ulcer-related osteomyelitis

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
timeFrame: 2 years after antibiotic therapy disruption
Secondary outcomes:
measure: 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
timeFrame: 2 years after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse
Study officials:
affiliation: Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse
name: Tristan Ferry
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.