SAVE Studie- SArcoma Surgery with Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Mar 16, 2025
Trial Information
Current as of May 09, 2025
Recruiting
Keywords
ClinConnect Summary
The SAVE Study is a clinical trial designed to improve how we manage wounds after surgery for soft tissue sarcomas, which are tumors that can occur in the groin and thigh areas. Researchers want to compare two different methods of closing the wound after surgery: one uses a special vacuum-assisted device to help heal the area, while the other involves traditional sutures and drainage. The goal is to see which method leads to fewer complications, such as infections or fluid build-up.
To participate in the study, patients need to be at least 18 years old and have a tumor that is at least 5 cm in size, located in the lower body. This trial is open to all genders and backgrounds. Participants will have their surgery as planned, and they will be monitored for any issues related to the wound healing process. If you or a loved one are considering joining this study, it’s important to discuss it with your healthcare team to see if you meet the eligibility criteria and to understand what participation would involve.
Gender
ALL
Eligibility 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.
About Universitätsklinikum Hamburg Eppendorf
Universitätsklinikum Hamburg-Eppendorf (UKE) is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, UKE integrates state-of-the-art facilities with a multidisciplinary approach, fostering collaboration among top-tier researchers, clinicians, and healthcare professionals. The institution is dedicated to improving patient outcomes by conducting rigorous scientific investigations that address critical health challenges, ultimately contributing to the development of novel therapies and enhancing medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamburg, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported