Comparing wound management techniques after sarcoma surgery
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery
NA · Universitätsklinikum Hamburg-Eppendorf · NCT06889532
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT06889532 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with soft tissue sarcomas larger than 5 cm located in the lower extremity or groin.
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.
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 performed: Other studies have shown promise in using vacuum-assisted closure for wound management, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Soft Tissue Sarcoma, randomized, controlled, vacuum therapy, sarcoma, soft tissue sarcoma