Condition or disease |
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Pressure-related Osteitis |
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.
Study Type : | Observational |
Actual Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen |
Actual Study Start Date : | May 20, 2019 |
Actual Primary Completion Date : | October 1, 2019 |
Actual Study Completion Date : | October 1, 2019 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
France | |
Infectious Diseases Department - Raymond Poincaré University Hospital | |
Garches, Hauts-de-Seine, France, 92380 |
Principal Investigator: | Aurélien DINH, MD | Infectious Diseases Department - Raymond Poincaré University Hospital |
Tracking Information | |||||
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First Submitted Date | May 14, 2019 | ||||
First Posted Date | May 28, 2019 | ||||
Last Update Posted Date | October 4, 2019 | ||||
Actual Study Start Date | May 20, 2019 | ||||
Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Occurrence of treatment failures at Day 45 after surgery [ Time Frame: at 45 days ] 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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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 | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment. | ||||
Condition | Pressure-related Osteitis | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
400 | ||||
Original Actual Enrollment |
300 | ||||
Actual Study Completion Date | October 1, 2019 | ||||
Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03964818 | ||||
Other Study ID Numbers | 19ADH-SCAR | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
Study Sponsor | Assistance Publique - Hôpitaux de Paris | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||
Verification Date | May 2019 |