Pressure-related OsteitisSCARNCT03964818
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
An observational study of Pressure-related Osteitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure-related Osteitis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.
Who may be able to join
- Patient ≥ 18 years;
- Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.
Who cannot join
- Patient < 18 years;
- Patient under under guardianship;
- Patient with concomitant infections;
- Patient having declare his opposition to study participation.
Trial locations and contacts
1 site in 1 country.
France1 site
Infectious Diseases Department - Raymond Poincaré University Hospital
Garches, Hauts-de-Seine, 92380
About this study
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.
Read the 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.
- Conditions
- Pressure-related Osteitis
- Keywords
- osteitis, flap surgery, short-course antibiotics
- Medical subject headings
- Osteitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 45 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: at 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start20 May 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure-related OsteitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien DINH, MD, Principal investigator, Infectious Diseases Department - Raymond Poincaré University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964818
- Sponsor's protocol ID
- 19ADH-SCAR
- Acronym
- SCAR
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
- ClinicalTrials.gov ID
- NCT03964818
- Acronym / sponsor ID
- SCAR / 19ADH-SCAR
- Conditions
- Pressure-related Osteitis
- Keywords
- osteitis, flap surgery, short-course antibiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.
Key inclusion criteria (2 listed)
- Patient ≥ 18 years;
- Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.
Key exclusion criteria (4 listed)
- Patient < 18 years;
- Patient under under guardianship;
- Patient with concomitant infections;
- Patient having declare his opposition to study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Risk factors associated with the occurrence of treatment failure at Day 45 after surgery
Time frame: at 45 days
Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery
Time frame: at 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien DINH, MD principal investigator
Infectious Diseases Department - Raymond Poincaré University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure-related Osteitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment failures at Day 45 after surgery (time frame: at 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.