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Clinical Trials/NCT05189392
NCT05189392Not yet recruitingNot Applicable

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 sites in 1 country42 target enrollmentStarted: January 10, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
2
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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