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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03010293

Collaborator

(none)

Enrollment

Location

8.5

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Diseases, Infectious

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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 Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Feb 15, 2017

Actual Study Completion Date :

Feb 15, 2017

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.