Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06941194

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

Led by Istituto Oncologico Veneto IRCCS · Updated on 2025-12-02

48

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18 years of age or older
  • Diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs confirmed by histopathology
  • Received neoadjuvant radiotherapy (short or long-term)
  • Candidates for wide radical excision surgery
  • Negative CT scan staging for distant metastasis
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of benign neoplasm
  • Diagnosis of retroperitoneal or trunk sarcomas
  • Candidates for hindquarter or forequarter amputation surgery
  • Incomplete wide excision
  • Vascular resection
  • Received other loco-regional treatments such as isolated limb perfusion or electrochemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Oncologico Veneto

Padova, Italy/Padova, Italy, 35128

Actively Recruiting

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Research Team

M

Marcodomenico Mazza, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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