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

NCT05713149 — Recruiting, 400 participants, Institut de Sante Parasport Connecte Synergies

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

Registry	NCT05713149
Status	Recruiting
Study type	Observational
Enrollment	400 (Estimated)
Sponsor	Institut de Sante Parasport Connecte Synergies (Other); collaborators: Assistance Publique - Hôpitaux de Paris
Conditions	Disability or Chronic Disease Leading to Disablement, Pressure Ulcer, Osteomyelitis
Interventions	Surgical flap and anti-bacterial agents (Other)
Dates	start 2023-02-19, primary completion 2026-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2023-02-06, last updated 2023-02-21
Locations	1 site in France

-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.

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+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.

+Arms and interventions

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

Surgical flap and anti-bacterial agents (Other): Surgical flap and anti-bacterial agents

+Outcome measures

Primary outcomes

Success at 12 months after surgery [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.

Secondary outcomes

Success at 30-45 days after surgery [30-45 days after surgery (depening on the surgical technique)]: 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.
Description of the patients' bacteriological tests [Through hospital admission, up to 7 days after surgery]: Intraoperative samples and drain samples.
Death [12 months after surgery]: Obtained from the INSEE database.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garches	France	Recruiting

+Investigators

François Genêt, MD-PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France