SarcomaPRALISSNCT06941194
Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery
A study testing PICO 14 in people with Sarcoma and Sarcoma,Soft Tissue, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sarcoma, Sarcoma,Soft Tissue
- What is being tested?
- PICO 14
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs (confirmed histopathologically)
- performed neoadjuvant radiotherapy (short or long-term)
- candidates for wide radical excision surgery
- negative CT scan staging for distant metastasis
- Signing of Informed consent
Who cannot join
- diagnosis of benign neoplasm
- diagnosis of retroperitoneal or trunk sarcomas;
- candidates to hindquarter or forequarter amputation surgery;
- incomplete wide excision;
- vascular resection;
- other loco-regional treatments (e.g. isolated limb perfusion or electrochemotherapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Oncologico Veneto
Padova, Italy/Padova, 35128
Marcodomenico Mazza, MD, 34722887055, marcodomenico.mazza@iov.veneto.it
About this study
Official title: Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial
Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. ECOG performance status will be reported. If inclusion criteria are respected, the patient will be randomized. The application of the PICO14 study device or standard dressing (dry gauze and plaster) will then be carried out on the day of surgery. For subjects randomized to the treatment arm (Arm A), dressing change with the application of the new PICO14 will occur at day 4+1, day 8±1, and day 14±2. For subjects randomized to the control arm (Arm B), the standard dressing with gauze and plaster is applied. Regardless of the randomization arm the wound assessment via ASEPSIS score will occur at day 4+1, 8±1 and 14±2. During FUP, the dressing can be changed autonomously by the patient if necessary. The information will be recorded on the occasion of the next visit or an extraordinary visit. On day 21, sutures will be removed.
On day 30±2, the total ASEPSIS score will be calculated, in order to evaluate the wound healing.
Read more
From day 14±2, regardless of the randomization arm all patients will be treated with standard dressing.
Follow-up visits can be scheduled up to 90 days after surgery.
- Conditions
- Sarcoma, Sarcoma,Soft Tissue
- Being tested
- PICO 14
- Keywords
- sarcoma, limbs, high-grade (grade III) soft tissue sarcoma, PICO14
- Medical subject headings
- Sarcoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO 14Device
PICO 14 application after neoadjuvant radiotherapy followed by surgery
| Study group | Role | What they receive |
|---|---|---|
| PICO14 | Experimental | PICO14 is a dressing designed to allow uniform distribution of negative pressure over the surface of a closed surgical incision and is classified as a Class IIb medical device according to Medical Device Directive 93/42/EEC and s.a.u. PICO14 (trade name) has been granted the CE marking in 1994 according to the Medical Device Directive 93/42/EEC and s.a.u.
It is a portable device, without collection canister, consisting of a sterile pump connected to a multilayer adhesive dressing. The pump is powered by two batteries which provide the continuous negative pressure. The PICO 14 dual dressing kit is intended to be used for up to 14 days on low to moderately exuding wounds. Receives: Device: PICO 14 |
| Control | No intervention | patient receive only standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective and endpoint
Assess, in patients with wide excision surgery of radio treated limb sarcoma, if the preventive application of single-use negative pressure wound dressing (PICO 14) may reduce the incidence of wound complications at 30° day compared to the standard procedure currently in use. Primary objective will be evaluated according to the ASEPSIS score. For each patient the Daily ASEPSIS score will be calculated at days 4, 8 and 14 after surgery.
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Secondary objective and endpoint
Evaluate and compare the incidence of long-term wound complications. All complications occurred between day 31 and day 90 after surgery will be collected and reported at the time of appearance, by ASEPSIS score
Measured: Through study completion, an average of 2 years
Third objective and endpoint
Verify the impact of the type of wound dressing in the length of hospital-stay. 2. The length of hospital stay will be calculated as the difference between the date of hospital discharge and the date of surgery
Measured: Through study completion, an average of 2 years
Fourth objective and endpoint
Evaluate the outpatient care time. 3. Outpatient care time will be calculated as the difference between the date of the last outpatient medication and the date of discharge.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941194
- Sponsor's protocol ID
- IOV-SA-01-2024-PRALISS
- Acronym
- PRALISS
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06941194
- Acronym / sponsor ID
- PRALISS / IOV-SA-01-2024-PRALISS
- Conditions
- Sarcoma, Sarcoma,Soft Tissue
- Keywords
- sarcoma, limbs, high-grade (grade III) soft tissue sarcoma, PICO14
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Apr 2025 (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.
Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. ECOG performance status will be reported. If inclusion criteria are respected, the patient will be randomized. The application of the PICO14 study device or standard dressing (dry gauze and plaster) will then be carried out on the day of surgery. For subjects randomized to the treatment arm (Arm A), dressing change with the application of the new PICO14 will occur at day 4+1, day 8±1, and day 14±2. For subjects randomized to the control arm (Arm B), the standard dressing with gauze and plaster is applied. Regardless of the randomization arm the wound assessment via ASEPSIS score will occur at day 4+1, 8±1 and 14±2. During FUP, the dressing can be changed autonomously by the patient if necessary. The information will be recorded on the occasion of the next visit or an extraordinary visit. On day 21, sutures will be removed.
On day 30±2, the total ASEPSIS score will be calculated, in order to evaluate the wound healing.
From day 14±2, regardless of the randomization arm all patients will be treated with standard dressing.
Follow-up visits can be scheduled up to 90 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO14 | Experimental | Device: PICO 14PICO14 is a dressing designed to allow uniform distribution of negative pressure over the surface of a closed surgical incision and is classified as a Class IIb medical device according to Medical Device Directive 93/42/EEC and s.a.u. PICO14 (trade name) has been granted the CE marking in 1994 according to the Medical Device Directive 93/42/EEC and s.a.u. It is a portable device, without collection canister, consisting of a sterile pump connected to a multilayer adhesive dressing. The pump is powered by two batteries which provide the continuous negative pressure. The PICO 14 dual dressing kit is intended to be used for up to 14 days on low to moderately exuding wounds. |
| Control | No intervention | –patient receive only standard therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age
- diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs (confirmed histopathologically)
- performed neoadjuvant radiotherapy (short or long-term)
- candidates for wide radical excision surgery
- negative CT scan staging for distant metastasis
Key exclusion criteria (6 listed)
- diagnosis of benign neoplasm
- diagnosis of retroperitoneal or trunk sarcomas;
- candidates to hindquarter or forequarter amputation surgery;
- incomplete wide excision;
- vascular resection;
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 |
|---|---|---|
| PICO 14PICO 14 application after neoadjuvant radiotherapy followed by surgery | Device | PICO14 |
Primary outcome
Primary objective and endpoint
Time frame: Through study completion, an average of 2 years
Assess, in patients with wide excision surgery of radio treated limb sarcoma, if the preventive application of single-use negative pressure wound dressing (PICO 14) may reduce the incidence of wound complications at 30° day compared to the standard procedure currently in use. Primary objective will be evaluated according to the ASEPSIS score. For each patient the Daily ASEPSIS score will be calculated at days 4, 8 and 14 after surgery.
3 secondary outcomes
Secondary objective and endpoint
Time frame: Through study completion, an average of 2 years
Third objective and endpoint
Time frame: Through study completion, an average of 2 years
Fourth objective and endpoint
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
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 14 in people with Sarcoma and Sarcoma,Soft Tissue, run by Istituto Oncologico Veneto IRCCS 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcodomenico Mazza, MD (34722887055, marcodomenico.mazza@iov.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective and endpoint (time frame: Through study completion, an average of 2 years). 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 2 Dec 2025.