Evaluate Postsurgical HematomaPICO-PTANCT05189392
Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
A study testing PICO in people with Evaluate Postsurgical Hematoma, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Evaluate Postsurgical Hematoma
- What is being tested?
- PICO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Ortopedico Galeazzi
Milan, MI, 20161
Cesare Donarini, 0248785220, cesare.donarini@grupposandonato.it
About this study
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
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
- Being tested
- PICO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICODevice
Also called Opsite Visible
after hip arthroplasty application of visible opsite plaster on the surgical wound
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PICO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Jan 2022 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Postsurgical HematomaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 21 patients with visible opsite patch and 21 patients with PICO
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189392
- Sponsor's protocol ID
- PICO-PTA
- Acronym
- PICO-PTA
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05189392
- Acronym / sponsor ID
- PICO-PTA / PICO-PTA
- Conditions
- Evaluate Postsurgical Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 21 patients with visible opsite patch and 21 patients with PICO
| Arm | Type | Receives |
|---|---|---|
| 21 patients with opsite visible | No intervention | –application of visible opsite plaster on the surgical wound after hip arthroplasty |
| 21 patients with PICO | Experimental | Device: PICOapplication of PICO on the surgical wound after hip arthroplasty |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICOAlso: Opsite Visibleafter hip arthroplasty application of visible opsite plaster on the surgical wound | Device | 21 patients with PICO |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO in people with Evaluate Postsurgical Hematoma, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesare Donarini (0248785220, cesare.donarini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.