NCT06941194 Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery
| NCT ID | NCT06941194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-09-15 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941194 currently recruiting?
Yes, NCT06941194 is actively recruiting participants. Contact the research team at marcodomenico.mazza@iov.veneto.it for enrollment information.
Where is the NCT06941194 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT06941194 clinical trial?
NCT06941194 is sponsored by Istituto Oncologico Veneto IRCCS. The trial plans to enroll 48 participants.