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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Maastricht University Medical Center

Collaborator

University Hospital, Basel, Switzerland

Collaborator

University Hospital Erlangen

Collaborator

Universitätsmedizin Mannheim

Collaborator