Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

Sponsor

Institut de Sante Parasport Connecte Synergies (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05713149

Collaborator

Assistance Publique - Hôpitaux de Paris (Other)

400

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disability or Chronic Disease Leading to Disablement Pressure Ulcer Osteomyelitis	Other: Surgical flap and anti-bacterial agents

Detailed Description

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.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cohort of Patients With Neuromotor Disability Treated for Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Subjects with osteomyelitis-associated pressure ulcers Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers	Other: Surgical flap and anti-bacterial agents Surgical flap and anti-bacterial agents

Arm

Intervention/Treatment

Subjects with osteomyelitis-associated pressure ulcers

Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers

Other: Surgical flap and anti-bacterial agents

Surgical flap and anti-bacterial agents

Outcome Measures

Primary Outcome Measures

Success at 30-45 days after surgery [30-45 days after surgery (depening on the surgical technique)]
Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of inflammatory signs or deep disunion of more than 2 cm.

Secondary Outcome Measures

Success at 12 months after surgery [12 months after surgery]
Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of inflammatory signs or deep disunion of more than 2 cm.
Description of the patients' bacteriological tests [Through hospital admission, up to 7 days after surgery]
Intraoperative samples and drain samples.
Death [12 months after surgery]
Obtained from the INSEE database.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garches		France	92380

Sponsors and Collaborators

Institut de Sante Parasport Connecte Synergies
Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: François Genêt, MD-PhD, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France