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出境医 / 临床实验 / Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen (SCAR)

Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen (SCAR)

Study Description
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.

Condition or disease
Pressure-related Osteitis

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
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Risk factors associated with the occurrence of treatment failure at Day 45 after surgery [ Time Frame: at 45 days ]
    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.

  2. Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery [ Time Frame: at 45 days ]
    Comparison between 7 days and 10 days of antibiotic treatment duration on the number of patients presenting treatment failure at Day 45 after surgery.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.
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.
Contacts and Locations

Locations
Layout table for location information
France
Infectious Diseases Department - Raymond Poincaré University Hospital
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Aurélien DINH, MD Infectious Diseases Department - Raymond Poincaré University Hospital
Tracking Information
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
 (submitted: May 24, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 24, 2019)
  • Risk factors associated with the occurrence of treatment failure at Day 45 after surgery [ Time Frame: at 45 days ]
    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.
  • Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery [ Time Frame: at 45 days ]
    Comparison between 7 days and 10 days of antibiotic treatment duration on the number of patients presenting treatment failure at Day 45 after surgery.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2019)
400
Original Actual Enrollment
 (submitted: May 24, 2019)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Aurélien DINH, MD Infectious Diseases Department - Raymond Poincaré University Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2019