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

Official title

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

Overview

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.

Interventions

• Device PICO 14
  PICO 14 application after neoadjuvant radiotherapy followed by surgery

Primary outcome measures

• Primary objective and endpoint [Time frame: Through study completion, an average of 2 years]

Secondary outcome measures (3)

• Secondary objective and endpoint [Time frame: Through study completion, an average of 2 years]
• Third objective and endpoint [Time frame: Through study completion, an average of 2 years]
• Fourth objective and endpoint [Time frame: Through study completion, an average of 2 years]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Istituto Oncologico Veneto — Padova

Identifiers

NCT: NCT06941194 · IOV-SA-01-2024-PRALISS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗