Testing a single-use pressure dressing after limb sarcoma surgery in radiated patients
Tests a single-use negative pressure wound dressing in adults after sarcoma surgery.
Plain-language title generated from the registry record
Registry title: Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery
Key facts
- Where
- Padova, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06941194, who can take part
Where in Italy
- Istituto Oncologico VenetoPadova, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Oncologico Veneto IRCCS
- Trial code
- NCT06941194
- Record updated
- 2 December 2025
- Original description
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.Read full original descriptionShow less
Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial
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.
Inclusion: 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: candidates to hindquarter or forequarter amputation surgery; vascular resection; diagnosis of benign neoplasm; diagnosis of retroperitoneal or trunk sarcomas; incomplete wide excision; other loco-regional treatments (e.g. isolated limb perfusion or electrochemotherapy).