Clinical Trials Directory

Trials / Completed

CompletedNCT03010293

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
Phase
Study type
Observational
Enrollment
61 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2016-06-01
Primary completion
2017-02-15
Completion
2017-02-15
First posted
2017-01-05
Last updated
2017-11-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03010293. Inclusion in this directory is not an endorsement.