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RecruitingNCT05713149Updated Feb 21, 2023

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

An observational study in Disability or Chronic Disease Leading to Disablement, Pressure Ulcer and Osteomyelitis, sponsored by Institut de Sante Parasport Connecte Synergies. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Institut de Sante Parasport Connecte Synergies · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

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

Keywords

  • Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 400 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Institut de Sante Parasport Connecte Synergies is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Under court protection.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherSurgical flap and anti-bacterial agents

    Surgical flap and anti-bacterial agents

06

What researchers measure

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 surgery

Secondary 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 surgery

  3. Death

    Obtained from the INSEE database.

    Time frame: 12 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
    Garches, 92380, France
    Recruiting
    • François Genêt, MD-PhD · Contact
    • François Genêt · Principal investigator
    • Hélène Le Liepvre · Sub investigator
    • Vincent T. Carpentier · Sub investigator
    • Aurélien Dinh · Sub investigator
    • Emma D'Anglejan Chatillon · Sub investigator
    • Latifa Noussair · Sub investigator
    • Damien Marmouset · Sub investigator
    • Haude Chaussard · Sub investigator
    • Mikaël Hivelin · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Feb 2026, 35 months after the start.

Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2023
First posted
Feb 6, 2023
StartActual
Feb 19, 2023
Primary completionEst.
Feb 1, 2026
CompletionEst.
Feb 1, 2027
Last update
Feb 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05713149
Lead sponsor
Institut de Sante Parasport Connecte Synergies
Collaborators
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Feb 6, 2023
Start date
Feb 19, 2023
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Feb 21, 2023

Study contacts

François Genêt, MD-PhD
Contact
françois.genet@aphp.fr
+ 33 1 47 10 70 82
Vincent T. Carpentier, MD-MSc
Contact
vincent.carpentier@ispc-synergies.org
+ 33 1 47 10 70 82
François Genêt, MD-PhD
principal investigator · Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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