NCT05713149 Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
| NCT ID | NCT05713149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut de Sante Parasport Connecte Synergies |
| Condition | Disability or Chronic Disease Leading to Disablement |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-02-19 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-02-19 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
François Genêt, MD-PhD
PRINCIPAL INVESTIGATOR
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
Frequently Asked Questions
Who can join the NCT05713149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disability or Chronic Disease Leading to Disablement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05713149 currently recruiting?
Yes, NCT05713149 is actively recruiting participants. Contact the research team at françois.genet@aphp.fr for enrollment information.
Where is the NCT05713149 trial being conducted?
This trial is being conducted at Garches, France.
Who is sponsoring the NCT05713149 clinical trial?
NCT05713149 is sponsored by Institut de Sante Parasport Connecte Synergies. The principal investigator is François Genêt, MD-PhD at Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France. The trial plans to enroll 400 participants.