Status:
RECRUITING
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Maastricht University Medical Center
University Hospital, Basel, Switzerland
Conditions:
Soft Tissue Sarcoma (STS)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The study, "SAVE Study - SArcoma Surgery with Vacuum Enhanced Wound Treatment," is a prospective, ran-domized, controlled clinical trial aimed at comparing the effectiveness of two surgical approaches...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06889532
Start Date
November 1 2024
End Date
December 31 2025
Last Update
March 21 2025
Active Locations (1)
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1
Universitätsklinikum Hamburg Eppendorf
Hamburg, Hamburg, Germany, 20246