C49
Conditions
Interventions
Group 1: Control Group: Primary Closure after Resection of Sarcoma
Group 2: Intervention Group: Vacuum-Therapy after sarcoma resection with secondary wound closure
Sponsors
Universitätsklinikum Hamburg- Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients must be over 18 years old. - Patients of any gender and background - 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
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. - When direct closure is not possible during the initial surgery due to the extent of resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to compare wound complications after vacuum therapy versus direct closure. The primary endpoint is defined by the occurrence of any of the following: • Infection • Seroma • Abscess • Lymphatic fistula • Wound dehiscence • Revision surgery • Drainage secretion of >50ml/24h after 5 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Factors Influencing Wound Infection: - Use of drainage - Impact of different sarcoma entities - BMI, age, and smoking, as well as pre-existing conditions such as diabetes mellitus, cardiovascular diseases, and immunosuppression - Localization (difference between groin, upper, and lower leg) - Tumor size (difference between 5-10 cm and >10 cm) | — |
Countries
Germany, Netherlands, Switzerland
Contacts
Public ContactSimone Schewe
Universitätsklinikum Hamburg Eppendorf
Outcome results
None listed