Clinical trial NCT06941194: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcoma
Sarcoma,Soft Tissue
Keywords: sarcoma
limbs
high-grade (grade III) soft tissue sarcoma
PICO14
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Primary outcomes:
measure: Primary objective and endpoint
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Secondary objective and endpoint
timeFrame: Through study completion, an average of 2 years
measure: Third objective and endpoint
timeFrame: Through study completion, an average of 2 years
measure: Fourth objective and endpoint
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: Italy/Padova
Study officials:
References: