Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03964818
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: