An observational study in Pressure-related Osteitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Pressure ulcers associated with osteitis are frequent among patients with spinal cord injury (SCI), and optimal management is not well known. In a French referral center, debridement and flap coverage surgeries performed simultaneously are followed by a short antibiotic treatment targeting the bacteria involved. The aim of the study is to evaluate patient's outcome at Day 45 after surgery, and identify factors associated with failure.
Spinal cord injured (SCI) population is subject to pressure ulcers because of numerous risk factors: neurological disorders, which reduce ability to mobilization, potential, undernutrition, confinement to bed, and vascular disorders promoting the lesions.
Despite the attention given to preventative strategies, in this population, prevalence of pressure ulcers varies from 10% to 30%, with an annual incidence rates range ranging from 20%-% to 31%.
In community-dwelling SCI population, stages III and IV pressure ulcers account for 25% of total ulcers observed.
They are a major cause of healthcare centers admissions or homecare nursing. Duration of ulcers could vary from 1 week to 3 years.
Also, their occurrence is associated with potential repeated hospitalizations and with a longer length of stay. Furthermore, pressure ulcers are an important economic burden to the health care system.
Pressure ulcers interfere with the patient's physical, psychological, and social well-being and impact the overall quality of life.
Over recent years, an increased pressure ulcer prevalence has been reported. Therefore, they are frequent and their clinical spectrum is wide. They also readily become superinfected and can lead to sepsis.
Establishing the diagnosis of osteomyelitis in this setting is challenging, and physicians often struggle with the appropriate therapeutic management.
A recent review did not find evidence of benefit of antibacterial therapy in osteomyelitis associated with pressure ulcers without concomitant surgical debridement and wound coverage. But this type of management remains controversial.
In a French referral center, patients with pressure ulcer-related osteitis benefit from a one-stage surgical management with bone shaving and flap covering, followed by a probabilistic post-operative antibiotic treatment, secondarily adapted to peroperative samples, for a total duration of effective antibiotic treatment of 7 or 10 days.
Thus, the investigators aim to evaluate this original strategy, identify risk factors for failure, and focus on the role of antibiotic treatment.
11 studies on the registry are indexed under Osteitis; 1 is open to participants now.
Browse Osteitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic 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.
Exclusion Criteria:
Occurrence of treatment failures at Day 45 after surgery
Primary outcome is the number of patients presenting treatment failure during a 45-day follow-up period after surgery, defined as the presence of dehiscence, and/or local signs of inflammation, and/or sepsis, and/or additional antibiotic treatment.
Time frame: at 45 days
Risk factors associated with the occurrence of treatment failure at Day 45 after surgery
Risk factors among patients' baseline characteristics, biological or microbiological analysis, or antibiotic treatments, significantly associated with the occurrence of treatment failure during a 45-day follow up period after surgery.
Time frame: at 45 days
Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery
Comparison between 7 days and 10 days of antibiotic treatment duration on the number of patients presenting treatment failure at Day 45 after surgery.
Time frame: at 45 days
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →