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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with osteomyelitis-associated pressure ulcers | Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical flap and anti-bacterial agents | Other | Surgical flap and anti-bacterial agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success at 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. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Success at 30-45 days after surgery | 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. | 30-45 days after surgery (depening on the surgical technique) |
| Description of the patients' bacteriological tests |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Genêt, MD-PhD | Contact | + 33 1 47 10 70 82 | françois.genet@aphp.fr | |
| Vincent T. Carpentier, MD-MSc | Contact | + 33 1 47 10 70 82 | vincent.carpentier@ispc-synergies.org |
| Name | Affiliation | Role |
|---|---|---|
| François Genêt, MD-PhD | Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP | Recruiting | Garches | 92380 | France |
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Intraoperative samples and drain samples. |
| Through hospital admission, up to 7 days after surgery |
| Death | Obtained from the INSEE database. | 12 months after surgery |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013524 | Surgical Flaps |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D019738 | Surgically-Created Structures |
| D004864 | Equipment and Supplies |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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