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.
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.: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Wound complication — 3 Months The primary objective of the study is to compare wound complications after vacuum therapy versus direct closure.
Wound Infection — 3 Months
Wound Seroma — 3 Months Seroma in Wound
Lymphatic fistula — 3 Months Lymphatic fistula or Drainage secretion of \>50ml/24h after 5 postoperative days
Wound Dehiscence — 3 Months Wound dehiscence
Revision Surgery or conservative treatment — 3 Months If Revision surgery or antibiotic treatment is required due to a wound infection.
Trial sites (1)
Facility
City
Region
Status
Universitätsklinikum Hamburg Eppendorf
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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