NCT05713149

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Institut de Sante Parasport Connecte Synergies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers. The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples. The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

Detailed description

This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for osteomyelitis-associated pressure ulcer by surgical flaps and anti bacterial agents. All eligible inpatient subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps will be consecutively included. Patients are followed up in consultation at 30 or 45 days after surgery, and in consultation or teleconsultation at 12 months after surgery. Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations. Data related to sitting, nutrition, spasticity, bladder and bowel disorders, bacteriological sampling and antibiotic treatments will be collected. This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.

Conditions

• Disability or Chronic Disease Leading to Disablement
• Pressure Ulcer
• Osteomyelitis

Interventions

Type	Name	Description
OTHER	Surgical flap and anti-bacterial agents	Surgical flap and anti-bacterial agents

Timeline

• Start date: 2023-02-19
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2023-02-06
• Last updated: 2023-02-21

Locations

1 site across 1 country: France