Surgical and antibiotic treatment for pressure ulcers linked to osteomyelitis
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
Run by Institut de Sante Parasport Connecte Synergies · NCT05713149 · Data updated 2026-11-12
This study is testing if a combined surgery and antibiotic treatment can help people with neuromotor disabilities who have pressure ulcers linked to bone infections heal better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Institut de Sante Parasport Connecte Synergies Academic / other |
| Locations | 1 site (Garches) |
| Status | Recruiting |
| Started | February 19, 2023 |
| Main results expected | February 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | February 21, 2023 |
| Trial ID | NCT05713149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with neuromotor disabilities requiring treatment for osteomyelitis-associated pressure ulcers.
✕Probably not a fit
Patients under court protection may not benefit from this study due to eligibility restrictions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with neuromotor disabilities who are at high risk for osteomyelitis-associated pressure ulcers. It aims to evaluate the effectiveness of a one-stage surgical management approach, which includes bone shaving and flap coverage, followed by tailored antibiotic treatment. Patients will be monitored post-surgery at 30 or 45 days and again at 12 months to assess outcomes and identify factors influencing treatment success or failure. Data will be collected from medical records, covering various clinical and physiological parameters.
Why it matters
Potential benefit: If successful, this approach could improve healing outcomes for patients with complex pressure ulcers and reduce the risk of complications.
How similar studies have gone: While the management of osteomyelitis-associated pressure ulcers is controversial, similar surgical approaches have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, France Recruiting
Study contacts
- Principal investigator: François Genêt, MD-PhD — Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
- Study coordinator: François Genêt, MD-PhD
- Email: françois.genet@aphp.fr
- Phone: + 33 1 47 10 70 82
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.