Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty

Study Overview
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Brief Summary
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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 of local complications, undergoing hip arthroplasty

Official Title
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Effect of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty

Conditions
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Evaluate Postsurgical Hematoma

Intervention / Treatment
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* Device: PICO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 21 patients with visible opsite patch and 21 patients with PICO
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 21 patients with opsite visible<br>application of visible opsite plaster on the surgical wound after hip arthroplasty | |
| Experimental: 21 patients with PICO<br>application of PICO on the surgical wound after hip arthroplasty | Device: PICO<br>* after hip arthroplasty application of visible opsite plaster on the surgical wound<br>* Other names: Opsite Visible;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation | By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation | 8 day |