Actively Recruiting
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-03-21
100
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
U
Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor
M
Maastricht University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- 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.
You will not qualify if you...
- 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.
- Patients for whom direct closure is not possible during the initial surgery due to the extent of resection.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
Research Team
S
Simone Dr. med. Schewe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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