Actively Recruiting
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients with Neuromotor Disability: a Prospective Cohort Study
Led by Institut de Sante Parasport Connecte Synergies · Updated on 2023-02-21
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institut de Sante Parasport Connecte Synergies
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study people with neuromotor disabilities, such as those caused by spinal cord, brain, or peripheral nerve injuries, who are at high risk of developing pressure ulcers linked to bone infections called osteomyelitis. The purpose is to describe this group of patients and find factors that influence successful or unsuccessful treatment outcomes in this vulnerable population. The study is a prospective cohort conducted at a single center specialized in managing such cases. Patients included in the study are those admitted to the perioperative disability unit of a university hospital for treatment of osteomyelitis-associated pressure ulcers using surgical flaps to cover the affected area combined with antibiotic medications. The surgical approach involves bone shaving and flap coverage to close the wound, followed by antibiotics tailored based on samples taken during surgery. This is a routine care study without additional procedures for research purposes. Participants are followed up with clinic visits at 30 or 45 days after surgery, and again either in person or via teleconsultation 12 months post-surgery. Data is collected from medical records, including clinical exams, imaging, lab tests, and information about sitting, nutrition, spasticity, bladder and bowel function, bacterial testing, and antibiotic use. The main outcome measured is treatment success at 12 months after surgery, with secondary outcomes including success at 30-45 days, bacteriological test results, and death. The total duration of participation extends to one year after surgery.
CONDITIONS
Brief Title
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years old or older
- Treated in the Perioperative Disability Unit of the Physical Medicine and Rehabilitation Department
- Admitted for treatment of an osteomyelitis-associated pressure ulcer by surgical flap
- Have a neuromotor disability
- No opposition to enrollment from patient or legally authorized relative if patient is unable
- Affiliated with a social security scheme
You will not qualify if you...
- Under court protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days after surgery
Participants undergo surgical flap treatment and receive anti-bacterial agents as part of routine care for osteomyelitis-associated pressure ulcers.
Duration - 30 to 45 days after surgery
Participants are followed up in consultation or teleconsultation to assess recovery and treatment success.
1 to 2 visits depending on surgical technique
Duration - 12 months after surgery
Participants are monitored to assess long-term treatment success and survival outcomes.
1 visit (in-person or teleconsultation)
Trial Site Locations
Total: 1 location
1
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, France, 92380
Actively Recruiting
Research Team
F
François Genêt, MD-PhD
V
Vincent T. Carpentier, MD-MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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