NCT06889532 SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
| NCT ID | NCT06889532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Soft Tissue Sarcoma (STS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06889532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma (STS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06889532 currently recruiting?
Yes, NCT06889532 is actively recruiting participants. Contact the research team at s.schewe@uke.de for enrollment information.
Where is the NCT06889532 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT06889532 clinical trial?
NCT06889532 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 100 participants.