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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-19

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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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

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Disability or Chronic Disease Leading to Disablement Pressure Ulcer Osteomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with osteomyelitis-associated pressure ulcers

Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers

Surgical flap and anti-bacterial agents

Intervention Type OTHER

Surgical flap and anti-bacterial agents

Interventions

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Surgical flap and anti-bacterial agents

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients \>= 18 years old ;
* Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
* Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;
* Having a neuromotor disability;
* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
* Affiliation to a social security scheme.