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

NCT06941194 | Recruiting

• 1 other identifier: IOV-SA-01-2024-PRALISS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

sarcoma; limbs; high-grade (grade III) soft tissue sarcoma; PICO14

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary objective and endpoint

  Through study completion, an average of 2 years

• Third objective and endpoint

  Through study completion, an average of 2 years

• Fourth objective and endpoint

  Through study completion, an average of 2 years

Study Arms (2)

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.

Device: PICO 14

Control

NO INTERVENTION

patient receive only standard therapy

Interventions

PICO 14 DEVICE

PICO 14 application after neoadjuvant radiotherapy followed by surgery

PICO14

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto

Padua, Italy/Padova, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Sarcoma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Marcodomenico Mazza, MD

CONTACT

34722887055; marcodomenico.mazza@iov.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

IT (1)