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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 (PICO-PTA)

Primary Purpose

Evaluate Postsurgical Hematoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PICO
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Evaluate Postsurgical Hematoma

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

21 patients with opsite visible

21 patients with PICO

Arm Description

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

application of PICO on the surgical wound after hip arthroplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
December 29, 2021
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT05189392
Brief Title
Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Acronym
PICO-PTA
Official Title
Effect of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2022 (Anticipated)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
January 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluate Postsurgical Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
21 patients with visible opsite patch and 21 patients with PICO
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
21 patients with opsite visible
Arm Type
No Intervention
Arm Description
application of visible opsite plaster on the surgical wound after hip arthroplasty
Arm Title
21 patients with PICO
Arm Type
Experimental
Arm Description
application of PICO on the surgical wound after hip arthroplasty
Intervention Type
Device
Intervention Name(s)
PICO
Other Intervention Name(s)
Opsite Visible
Intervention Description
after hip arthroplasty application of visible opsite plaster on the surgical wound
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
8 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Donarini
Phone
0248785220
Email
cesare.donarini@grupposandonato.it
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milano
State/Province
MI
ZIP/Postal Code
20161
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesare Donarini
Phone
0248785220
Email
cesare.donarini@grupposandonato.it

12. IPD Sharing Statement

Learn more about this trial

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

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