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SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery

RecruitingNAAges 18 Years - anyAllUniversitätsklinikum Hamburg-Eppendorf
NCT06889532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.
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Where

1 site
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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