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

NCT ID: NCT06941194

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-11-30

Brief 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. 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.

Conditions

Sarcoma; Sarcoma,Soft Tissue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PICO 14

Intervention Type: DEVICE

PICO 14 application after neoadjuvant radiotherapy followed by surgery

Control

patient receive only standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PICO 14

PICO 14 application after neoadjuvant radiotherapy followed by surgery

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Oncologico Veneto

Padua, Italy/Padova, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marcodomenico Mazza, MD

Role: CONTACT

marcodomenico.mazza@iov.veneto.it

34722887055

Facility Contacts

Marcodomenico Mazza, MD

Role: primary

marcodomenico.mazza@iov.veneto.it

34722887055

Other Identifiers

IOV-SA-01-2024-PRALISS

Identifier Type: -

Identifier Source: org_study_id