RecruitingNot ApplicableNCT06941194

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

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


Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

48 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether applying a single-use negative pressure wound device (a special dressing that uses gentle suction to promote healing) after surgery reduces wound complications in patients with limb sarcoma who received radiation before their operation. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-grade soft tissue sarcoma of an arm or leg (confirmed by biopsy) - You received radiation therapy (neoadjuvant) before surgery - You are scheduled for wide surgical removal of the tumor - Your scans show no distant spread (metastasis) **You may NOT be eligible if...** - Your tumor is in the abdomen/back area (retroperitoneal or trunk) - You are a candidate for limb amputation - Your surgery would involve removing a major blood vessel - You have received other local treatments like limb perfusion or electrochemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPICO 14

PICO 14 application after neoadjuvant radiotherapy followed by surgery


Locations(1)

Istituto Oncologico Veneto

Padova, Italy/Padova, Italy

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NCT06941194


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