NCT06889532Recruiting
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to evaluate local complications following sarcoma resection in the groin and thigh regions with regard to the planned wound closure method. To this end, temporary soft tissue coverage using a vacuum-assisted closure (VAC) system and delayed secondary closure with wound sutures and drainage placement will be compared to primary closure with drainage in terms of wound infections, revisions, and seroma formation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 23 Feb 2025
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- Sarcoma
- NCT number
- NCT06889532
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Nov 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with local recurrences or prior wound healing complications in the surgical area.
- for whom direct closure is not possible during the initial surgery due to the extent of resection.
Other illness
- Patients with ulcerating or infected tumors, or those requiring emergency surgery.
Other
- Tumors smaller than 5 cm and superficial masses.
- Other Soft Tissue Tumors such as Kaposi sarcoma.
Who the study is looking for
- Patients must be over 18 years old.
- Patients of any gender and background can be included.
- The largest tumor diameter on imaging must be at least 5 cm. Preoperative imaging is required to assess tumor dimensions.
- Sarcomas must be located in the lower extremity or groin.
- Cases must be discussed preoperatively at an interdisciplinary tumor board.
- Patients must provide informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.