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

RecruitingNAAges 18 Years - 99 YearsAllIstituto Oncologico Veneto IRCCS
NCT06941194 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • PICO 14
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Where

1 site
Istituto Oncologico Veneto
Padova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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