Preventing wound complications after limb sarcoma surgery with a single-use negative-pressure dressing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults meeting screening criteria are randomized at pre-admission to receive either the PICO14 single-use negative-pressure dressing or standard gauze-and-plaster dressings on the day of wide excision surgery. For those in the PICO14 arm, dressings are renewed around day 4, day 8, and day 14; both arms undergo wound assessment using the ASEPSIS score at those same time points. Eligibility requires histologically confirmed grade III soft-tissue sarcoma of a limb, neoadjuvant radiotherapy, negative CT staging for metastases, and candidacy for wide excision; several local or amputation procedures are excluded. Patients may change dressings themselves during follow-up if needed and outcomes focus on postoperative wound healing and complications.

Why it matters

Who can join: the full rules

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).

Where it's running

• Istituto Oncologico Veneto
  Padova, Italy/Padova, Italy Recruiting

Study contacts

• Study coordinator: Marcodomenico Mazza, MD
• Email: marcodomenico.mazza@iov.veneto.it
• Phone: 34722887055

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.