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

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcer; Osteomyelitis; Disability or Chronic Disease Leading to Disablement
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the patients' bacteriological tests	Intraoperative samples and drain samples.	Through hospital admission, up to 7 days after surgery
Death	Obtained from the INSEE database.	12 months after surgery
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)

Collaborators and Investigators

• Sponsor: Institut de Sante Parasport Connecte Synergies
• Collaborators: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2023
• Primary Completion (Anticipated): February 1, 2026
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Disease Attributes; Skin Ulcer; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Ulcer; Chronic Disease; Pressure Ulcer; Osteomyelitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2023-001 (University of Missouri)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No