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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Garches, Hauts-de-Seine, France, 92380
      • Infectious Diseases Department - Raymond Poincaré University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 45 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Aurélien DINH, MD, Infectious Diseases Department - Raymond Poincaré University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: osteitis; flap surgery; short-course antibiotics
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Musculoskeletal Diseases; Bone Diseases; Osteitis; Pressure Ulcer
• Other Study ID Numbers: 19ADH-SCAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No