Status:
UNKNOWN
Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Evaluate Postsurgical Hematoma
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk...
Eligibility Criteria
Inclusion
- aged between 55 and 85 years inclusive,
- Patients with BMI ≥ 30 + ASA 3 + Diabetes mellitus
- Patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty
Exclusion
- Age\> 85 years, \<55 years
- Patients who are unable to understand and want.
- Patients with severe neurological disorders or with severe disabilities.
- Oncological patients and patients with malignant tumor at the edge of the wound
- Patients who have undergone radiotherapy treatment
- Patients with bleeding disorders
- Patients on anticoagulant treatment with warfarin or NAO
- Previously confirmed osteomyelitis
- Patients with liver cirrhosis
- Patients with non-enteric fistulas
- Patients with necrotic tissue with the presence of eschar at the intervention site
- Patients with autoimmune thrombocytopenia.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05189392
Start Date
January 10 2022
End Date
January 10 2025
Last Update
January 12 2022
Active Locations (1)
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1
IRCCS Istituto Ortopedico Galeazzi
Milan, MI, Italy, 20161