Pressure-related Osteitis Clinical Trial
— SCAROfficial title:
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
NCT number | NCT03964818 |
Other study ID # | 19ADH-SCAR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | October 1, 2019 |
Verified date | May 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Infectious Diseases Department - Raymond Poincaré University Hospital | Garches | Hauts-de-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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 |