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

Launched by ISTITUTO ONCOLOGICO VENETO IRCCS · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of wound treatment called single-use negative pressure wound therapy (sNPWT) for patients who have had surgery for high-grade soft tissue sarcoma in the limbs after receiving radiation therapy. The goal is to see if this new dressing helps wounds heal better than the standard dressing of gauze and plaster. Patients who are at least 18 years old, have been diagnosed with a specific type of sarcoma, and have undergone radiation therapy may be eligible to participate in this trial.

If you join the trial, you will be randomly assigned to one of two groups: one will receive the new PICO14 dressing, while the other will get the standard dressing. You will have regular checks on your wound healing at specific days after surgery, and you can change your dressing at home if needed. The trial will follow you for up to 90 days after surgery, and your sutures will be removed around day 21. This study aims to understand which dressing works better for healing wounds in this specific patient group.

Gender

ALL

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).