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

NCT ID: NCT05189392

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-01-10

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

Detailed Description

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Conditions

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Evaluate Postsurgical Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

21 patients with visible opsite patch and 21 patients with PICO
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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21 patients with opsite visible

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

Group Type NO_INTERVENTION

No interventions assigned to this group

21 patients with PICO

application of PICO on the surgical wound after hip arthroplasty

Group Type EXPERIMENTAL

PICO

Intervention Type DEVICE

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

Interventions

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PICO

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

Intervention Type DEVICE

Other Intervention Names

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Opsite Visible

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, MI, Italy

Site Status

Countries

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Italy

Central Contacts

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Cesare Donarini

Role: CONTACT

0248785220

Facility Contacts

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Cesare Donarini

Role: primary

0248785220

Other Identifiers

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PICO-PTA

Identifier Type: -

Identifier Source: org_study_id

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