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Recruiting NCT05713149

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

— Observational Disability or Chronic Disease Leading to Disablement Pressure Ulcer Osteomyelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical flap and anti-bacterial agents.
Who it may be relevant to
Registry conditions: Disability or Chronic Disease Leading to Disablement, Pressure Ulcer, Osteomyelitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Surgical flap and anti-bacterial agents
    Surgical flap and anti-bacterial agents

Primary outcome measures

  • Success at 12 months after surgery [Time frame: 12 months after surgery]
Secondary outcome measures (3)
  • Success at 30-45 days after surgery [Time frame: 30-45 days after surgery (depening on the surgical technique)]
  • Description of the patients' bacteriological tests [Time frame: Through hospital admission, up to 7 days after surgery]
  • Death [Time frame: 12 months after surgery]

Eligibility criteria

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.

Exclusion criteria

  • Under court protection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP — Garches

Identifiers

NCT: NCT05713149 · 2023-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗