Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Istituto Oncologico Veneto
Padova, Italy/Padova, Italy, 35128
Actively Recruiting
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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