Clinical trial NCT03964818: Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
Official title: Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure-related Osteitis
Keywords: osteitis
flap surgery
short-course antibiotics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years;
* Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.

Exclusion Criteria:

* Patient \< 18 years;
* Patient under under guardianship;
* Patient with concomitant infections;
* Patient having declare his opposition to study participation.

Primary outcomes:
measure: Occurrence of treatment failures at Day 45 after surgery
timeFrame: at 45 days
Secondary outcomes:
measure: Risk factors associated with the occurrence of treatment failure at Day 45 after surgery
timeFrame: at 45 days
measure: Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery
timeFrame: at 45 days
Other outcomes:
Locations:
city: Garches
country: France
facility: Infectious Diseases Department - Raymond Poincaré University Hospital
state: Hauts-de-Seine
Study officials:
affiliation: Infectious Diseases Department - Raymond Poincaré University Hospital
name: Aurélien DINH, MD
role: PRINCIPAL_INVESTIGATOR
References: