Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05713149

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garches, 92380, France

Location status: Recruiting

Location contact

Aurélien Dinh

SUB_INVESTIGATOR

Damien Marmouset

SUB_INVESTIGATOR

Emma D'Anglejan Chatillon

SUB_INVESTIGATOR

François Genêt

PRINCIPAL_INVESTIGATOR

François Genêt, MD-PhD

CONTACT

Haude Chaussard

SUB_INVESTIGATOR

Hélène Le Liepvre

SUB_INVESTIGATOR

Latifa Noussair

SUB_INVESTIGATOR

Mikaël Hivelin

SUB_INVESTIGATOR

Vincent T. Carpentier

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical flap and anti-bacterial agents

Other

Surgical flap and anti-bacterial agents

Primary outcomes

  1. Success at 12 months after surgery

    Time frame: 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 outcomes

  1. Success at 30-45 days after surgery

    Time frame: 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.

  2. Description of the patients' bacteriological tests

    Time frame: Through hospital admission, up to 7 days after surgery

    Intraoperative samples and drain samples.

  3. Death

    Time frame: 12 months after surgery

    Obtained from the INSEE database.

Study contacts

Contact information is provided by the study sponsor or research team.

François Genêt, MD-PhD

CONTACT

franç[email protected]

+ 33 1 47 10 70 82

Vincent T. Carpentier, MD-MSc

CONTACT

[email protected]

+ 33 1 47 10 70 82

Sponsors and collaborators

Lead sponsor

Institut de Sante Parasport Connecte Synergies

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.