Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut de Sante Parasport Connecte Synergies
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Under court protection.
Trial population
Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical flap and anti-bacterial agents
Other interventionSurgical flap and anti-bacterial agents
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Subjects with osteomyelitis-associated pressure ulcers1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months after surgerySecondary outcomes
1
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.
Time frame
30-45 days after surgery (depening on the surgical technique)2
Description of the patients' bacteriological tests
Intraoperative samples and drain samples.
Time frame
Through hospital admission, up to 7 days after surgery3
Death
Obtained from the INSEE database.
Time frame
12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut de Sante Parasport Connecte Synergies
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
Source ClinicalTrials.gov