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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713149
• Other study ID #: 2023-001
• Status: Recruiting
• Start date: February 19, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: February 2023
• Source: Institut de Sante Parasport Connecte Synergies
• Contact: François Genêt, MD-PhD
• Phone: + 33 1 47 10 70 82
• Email: françois.genet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Disability or Chronic Disease Leading to Disablement
• Osteomyelitis
• Pressure Ulcer
• Ulcer

Intervention

Other:
• Surgical flap and anti-bacterial agents
Surgical flap and anti-bacterial agents

Locations

Country	Name	City	State
France	Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Sante Parasport Connecte Synergies	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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