Pressure-related Osteitis Clinical Trial
Official title:
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
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.
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