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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Not yet enrolling

Conditions

Evaluate Postsurgical Hematoma

Treatments

Device: PICO

Study type

Interventional

Funder types

Other

Identifiers

NCT05189392

PICO-PTA

Details and patient eligibility

About

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

Enrollment

42 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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.