RecruitingNot ApplicableNCT06889532

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

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrollment

100 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma (STS)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of managing surgical wounds after removing sarcomas (rare cancers of soft tissues or bone) in the leg or groin area: standard wound dressings versus vacuum-assisted wound closure (a sealed dressing connected to a gentle suction device). The goal is to reduce complications like infections or wound breakdown. **You may be eligible if...** - You are 18 or older - You have a sarcoma in the lower limb or groin area - The tumor is at least 5 cm in diameter on imaging - Your case has been reviewed by a multidisciplinary tumor board - You are willing and able to provide consent **You may NOT be eligible if...** - Your tumor is smaller than 5 cm - Your sarcoma is located outside the lower extremity or groin - You have conditions that make vacuum wound therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntervention 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.