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

Bone Diseases, Infectious Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010293
• Other study ID #: 69HCL16_0391
• Status: Completed
• Phase: N/A
• First received: January 2, 2017
• Last updated: November 7, 2017
• Start date: June 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Infectious
• Communicable Diseases
• Infection
• Osteomyelitis
• Pressure Ulcer

Locations

Country	Name	City	State
France	Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	2 years after antibiotic therapy disruption

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