Surgical and antibiotic treatment for pressure ulcers linked to osteomyelitis
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Sante Parasport Connecte Synergies Academic / other |
| Locations | 1 site (Garches) |
| Trial ID | NCT05713149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with neuromotor disabilities requiring treatment for osteomyelitis-associated pressure ulcers.
Not a fit: Patients under court protection may not benefit from this study due to eligibility restrictions.
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 performed: While the management of osteomyelitis-associated pressure ulcers is controversial, similar surgical approaches have shown promise in other studies, suggesting potential for success.
Eligibility criteria
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 this trial is running
Garches
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.