Disability or Chronic Disease Leading to DisablementNCT05713149
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
An observational study of Disability or Chronic Disease Leading to Disablement and Pressure Ulcer, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement, Pressure Ulcer, Osteomyelitis
- What is being tested?
- Surgical flap and anti-bacterial agents
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2023to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.
Who may be able to join
- 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.
Who cannot join
- Under court protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, 92380
François Genêt, MD-PhD
François Genêt
About this study
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
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.
Read the 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.
- Being tested
- Surgical flap and anti-bacterial agents
- Keywords
- Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture
- Medical subject headings
- Pressure Ulcer, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical flap and anti-bacterial agentsOther
Surgical flap and anti-bacterial agents
| Study group | Role | What they receive |
|---|---|---|
| Subjects with osteomyelitis-associated pressure ulcers | Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers Receives: Other: Surgical flap and anti-bacterial agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (3)
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.
Measured: 30-45 days after surgery (depening on the surgical technique)
Description of the patients' bacteriological tests
Intraoperative samples and drain samples.
Measured: Through hospital admission, up to 7 days after surgery
Death
Obtained from the INSEE database.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start19 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability or Chronic Disease Leading to DisablementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Sante Parasport Connecte Synergies
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD-PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713149
- Sponsor's protocol ID
- 2023-001
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05713149
- Acronym / sponsor ID
- 2023-001
- Keywords
- Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut de Sante Parasport Connecte SynergiesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 19 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with osteomyelitis-associated pressure ulcers | – | Other: Surgical flap and anti-bacterial agentsSubjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Under court protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical flap and anti-bacterial agentsSurgical flap and anti-bacterial agents | Other | Subjects with osteomyelitis-associated pressure ulcers |
Primary outcome
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.
3 secondary outcomes
Success at 30-45 days after surgery
Time frame: 30-45 days after surgery (depening on the surgical technique)
Description of the patients' bacteriological tests
Time frame: Through hospital admission, up to 7 days after surgery
Death
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Genêt, MD-PhD principal investigator
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability or Chronic Disease Leading to Disablement and Pressure Ulcer, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Genêt, MD-PhD (+ 33 1 47 10 70 82, françois.genet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success at 12 months after surgery (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.