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.
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.
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.
Parallel
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.
Procedure/SurgeryIntervention 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.
Wound complication
The primary objective of the study is to compare wound complications after vacuum therapy versus direct closure.
Wound Infection
Wound Seroma
Seroma in Wound
Lymphatic fistula
Lymphatic fistula or Drainage secretion of \>50ml/24h after 5 postoperative days
Risk factors for wound complications
In addition, the benefit of using drainage to prevent wound infections will be evaluated. For this, the type of drainage, the location of the drainage, the volume of secretion, and the duration of the drainage will be docu-mented. The impact of different sarcoma entities on the occurrence of wound infections will also be investi-gated. The effects of BMI, age, smoking, and pre-existing conditions such as diabetes mellitus, cardiovascular diseases, and immunosuppression will be assessed. A subgroup analysis will be performed to evaluate the relevance of neoadjuvant treatment. Furthermore, the influence of factors such as tumor location (differences between groin, thigh, and lower leg) and actual tumor size (differences between 5-10 cm and \>10 cm) will be examined.
Click on the lead sponsor to view all of their trials.
Universitätsklinikum Hamburg-Eppendorf
Lead sponsor
Maastricht University Medical Center
Collaborator
University Hospital, Basel, Switzerland
Collaborator
University Hospital Erlangen
Collaborator
Universitätsmedizin Mannheim
Collaborator
