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

I

Institut de Sante Parasport Connecte Synergies

Status

Enrolling

Conditions

Disability or Chronic Disease Leading to Disablement
Pressure Ulcer
Osteomyelitis

Treatments

Other: Surgical flap and anti-bacterial agents

Study type

Observational

Funder types

Other

Identifiers

NCT05713149
2023-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Subjects with osteomyelitis-associated pressure ulcers
Description:
Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers
Treatment:
Other: Surgical flap and anti-bacterial agents

Trial contacts and locations

1

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Central trial contact

Vincent T. Carpentier, MD-MSc; François Genêt, MD-PhD

Data sourced from clinicaltrials.gov

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