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

Pressure-related Osteitis Clinical Trial

— SCAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964818
• Other study ID #: 19ADH-SCAR
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The aim of the study is to evaluate patient's outcome at Day 45 after surgery, and identify factors associated with failure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteitis
• Pressure Ulcer
• Pressure-related Osteitis

Locations

Country	Name	City	State
France	Infectious Diseases Department - Raymond Poincaré University Hospital	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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