Actively Recruiting
SAVE Study - Sarcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate Wound Management in Sarcoma Surgery
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-03-21
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor
M
Maastricht University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating wound care methods following sarcoma surgery in the groin and thigh areas, focusing on local complications like infections, need for revision surgeries, and fluid buildup. This randomized controlled trial compares two wound closure techniques to find the best approach for healing after sarcoma removal in the lower extremity regions. The study aims to improve surgical outcomes by assessing wound complications over a three-month period. The trial includes two groups: one receives a vacuum-assisted closure (VAC) system applied during surgery with delayed secondary closure after 3 to 7 days, while the other group undergoes primary closure with sutures or staples and drainage placement. The VAC system uses controlled suction pressures to support wound healing, and all procedures are performed by certified sarcoma surgeons. Drainages are placed in both groups to manage wound fluids, and secondary closure timing in the VAC group is determined by the surgeon but must occur within seven days. Participants will be monitored for wound infections, seroma, lymphatic fistula, wound opening, and need for further surgery or treatment within three months after surgery. Researchers will collect data on risk factors contributing to wound complications. Eligible patients are adults undergoing sarcoma resection in the lower limb or groin, with tumors at least 5 cm in size. The study will recruit at least 100 patients across multiple centers starting November 2024, with follow-up evaluations to track healing and complications.
CONDITIONS
Brief Title
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- 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
You will not qualify if you...
- 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
- Patients for whom direct closure is not possible during the initial surgery due to the extent of resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 month before surgery
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - Day of surgery plus up to 7 days post-surgery
Participants undergo sarcoma surgery performed by a certified surgeon. Wound closure is done either with a vacuum-assisted closure (VAC) system followed by a secondary closure after 3 to 7 days, or with primary sutures or staples and drainage placement.
1 surgery visit and 1 to 2 post-operative visits depending on wound closure method
Duration - 3 months
Participants are monitored for wound healing, complications, and recovery for up to 3 months after surgery.
Periodic follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
Research Team
S
Simone Dr. med. Schewe
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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