New wound dressing aims to cut surgery complications in sarcoma patients
NCT ID NCT06941194
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a single-use negative pressure wound dressing (PICO14) can reduce wound problems after surgery for limb sarcoma in patients who had radiation therapy. About 48 adults will be randomly assigned to get either the special dressing or standard gauze. The main goal is to see if the special dressing leads to fewer wound complications within 30 days after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istituto Oncologico Veneto
RECRUITINGPadova, Italy/Padova, 35128, Italy
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