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

Istituto Oncologico Veneto IRCCS

Status: Enrolling

Conditions: Sarcoma; Sarcoma,Soft Tissue

Treatments: Device: PICO 14

Study type: Interventional

Funder types: Other

Identifiers

NCT06941194

IOV-SA-01-2024-PRALISS

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

PICO14

Experimental group

Description:

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.

Treatment:

Device: PICO 14

Control

No Intervention group

Description:

patient receive only standard therapy