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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05189392
Acronym
PICO-PTA
Enrollment
42
Registered
2022-01-12
Start date
2022-01-10
Completion date
2025-01-10
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluate Postsurgical Hematoma

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

Interventions

DEVICEPICO

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

21 patients with visible opsite patch and 21 patients with PICO

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 formation8 dayBy 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

Countries

Italy

Contacts

Primary ContactCesare Donarini
cesare.donarini@grupposandonato.it0248785220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026