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

Recruiting

• Conditions: Pressure Ulcer; Disability or Chronic Disease Leading to Disablement; Osteomyelitis

• Registration Number: NCT05713149
• Lead Sponsor: Institut de Sante Parasport Connecte Synergies

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.

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.

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.

Study Timeline

• Study First Submitted: 2023-01-18
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-06
• Last Update Submitted: 2023-02-18
• Study Start: 2023-02-19
• Last Update Posted: 2023-02-21
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 local care at the surgical site.

Secondary Outcome Measures

Name	Time	Method
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 pus leakage 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.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP; 🇫🇷 Garches, France