Preventing wound complications after limb sarcoma surgery with a single-use negative-pressure dressing
Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial
This test will try a single-use negative-pressure wound dressing (PICO14) to see if it reduces wound complications after limb high-grade soft tissue sarcoma surgery in adults who received preoperative radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Locations | 1 site (Padova, Italy/Padova) |
| Trial ID | NCT06941194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed high-grade (grade III) soft-tissue sarcoma of a limb who received neoadjuvant radiotherapy, are candidates for wide excision without distant metastases, and can give informed consent.
Not a fit: Patients with benign tumors, trunk or retroperitoneal sarcomas, planned forequarter/hindquarter amputation, incomplete excision, vascular resection, or who received other loco-regional treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, PICO14 could reduce postoperative wound infections and healing problems, leading to fewer reinterventions and faster recovery.
How similar studies have performed: Negative-pressure wound therapy has reduced wound complications in several high-risk surgical settings, but evidence is mixed and specifically limited for pre-radiated limb sarcoma resections.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Padova, Italy/Padova
- Istituto Oncologico Veneto — Padova, Italy/Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Marcodomenico Mazza, MD
- Email: marcodomenico.mazza@iov.veneto.it
- Phone: 34722887055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.