Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery (PRALISS)

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.

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 Overview

• Status: Recruiting
• Conditions: Sarcoma; Sarcoma,Soft Tissue
• Intervention / Treatment: Device: PICO 14

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcodomenico Mazza, MD; Phone Number: 34722887055; Email: marcodomenico.mazza@iov.veneto.it

Study Locations

• Italy
  • Italy/Padova
    • Padua, Italy/Padova, Italy, 35128
      • Recruiting
      • Istituto Oncologico Veneto
      • Contact: Marcodomenico Mazza, MD; Phone Number: 34722887055; Email: marcodomenico.mazza@iov.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO14; 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.	Device: PICO 14; PICO 14 application after neoadjuvant radiotherapy followed by surgery
No Intervention: Control; patient receive only standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Istituto Oncologico Veneto IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: sarcoma; limbs; high-grade (grade III) soft tissue sarcoma; PICO14
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Connective and Soft Tissue; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Sarcoma
• Other Study ID Numbers: IOV-SA-01-2024-PRALISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No