Comparing wound management techniques after sarcoma surgery
Official title: SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery
Run by Universitätsklinikum Hamburg-Eppendorf · NCT06889532 · Data updated 2026-11-12
This study is testing two different ways to close surgical wounds after sarcoma surgery in the groin and thigh to see which method leads to fewer complications like infections and fluid buildup.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | March 21, 2025 |
| Trial ID | NCT06889532 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with soft tissue sarcomas larger than 5 cm located in the lower extremity or groin.
✕Probably not a fit
Patients with tumors smaller than 5 cm, superficial masses, or those with prior wound healing complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates local complications following sarcoma resection in the groin and thigh regions by comparing two surgical wound closure methods. One group will receive vacuum-assisted closure (VAC) for temporary soft tissue coverage, while the other will undergo primary closure with sutures and drainage. The study is multicenter and randomized, ensuring balanced assignment of participants to each group. It aims to assess outcomes such as wound infections, revisions, and seroma formation.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing sarcoma surgery.
How similar studies have gone: Other studies have shown promise in using vacuum-assisted closure for wound management, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * Tumors smaller than 5 cm and superficial masses. * Patients with local recurrences or prior wound healing complications in the surgical area. * Patients with ulcerating or infected tumors, or those requiring emergency surgery. * Other Soft Tissue Tumors such as Kaposi sarcoma. * for whom direct closure is not possible during the initial surgery due to the extent of resection.
Where it's running
-
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
Study contacts
- Study coordinator: Simone Dr. med. Schewe
- Email: s.schewe@uke.de
- Phone: 015222841914
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.