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

NCT05189392 | Unknown

• 1 other identifier: PICO-PTA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 of local complications, undergoing hip arthroplasty

Conditions

Evaluate Postsurgical Hematoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

21 patients with opsite visible

NO INTERVENTION

application of visible opsite plaster on the surgical wound after hip arthroplasty

21 patients with PICO

EXPERIMENTAL

application of PICO on the surgical wound after hip arthroplasty

Device: PICO

Interventions

PICO DEVICE

after hip arthroplasty application of visible opsite plaster on the surgical wound

Also known as: Opsite Visible

21 patients with PICO

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

Location

Central Study Contacts

Cesare Donarini

CONTACT

0248785220; cesare.donarini@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 21 patients with visible opsite patch and 21 patients with PICO

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 12, 2022
• Study Start: January 10, 2022
• Primary Completion: December 10, 2024
• Study Completion: January 10, 2025
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

IT (1)