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L'essai clinique NCT05713149 pour Handicap ou maladie chronique entraînant une incapacité, Ulcère de pression, Ostéomyélite est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
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.
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.
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study
- 2023-001
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
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 Surgical flap and anti-bacterial agents |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Success at 12 months after surgery | Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of local care at the surgical site. | 12 months after surgery |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Success at 30-45 days after surgery | Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of inflammatory signs or pus leakage or deep disunion of more than 2 cm. | 30-45 days after surgery (depening on the surgical technique) |
Description of the patients' bacteriological tests | Intraoperative samples and drain samples. | Through hospital admission, up to 7 days after surgery |
Death | Obtained from the INSEE database. | 12 months after surgery |
- 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.
- Under court protection.
Institut de Sante Parasport Connecte SynergiesAssistance publique - Hôpitaux de Paris