Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy

Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03010293

Enrollment

Registered

2017-01-05

Start date

2016-06-30

Completion date

2017-02-15

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Infectious

Keywords

Antimicrobial therapy, Debridement, Osteomyelitis, Muscular flap, Pressure ulcer, Treatment failure, Vacuum-assisted closure therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis	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.

Secondary

Measure	Time frame	Description
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	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.

Countries

France

Outcome results