Grant: Project Grant

Soft tissue sarcomas are malignant tumors primarily affecting the arms, legs, and pelvis. They are treated with extensive limb salvage surgery combined with radiation therapy administered either before or after surgery. The treatment combination results in high wound break down rates requiring repeated surgeries and interventions, prolonged hospitalizations, and significant patient morbidity. Incisional Negative Pressure Wound Therapy (INPWT) is a wound management system which has the potential to decrease wound complications, simplify wound management, facilitate quicker hospital discharge and decreased hospital readmission rates. This wound therapy system has been used in different surgical specialties as cardiac surgery, vascular surgery and orthopedic surgery. It has been documented that the INPWT is beneficial for patients with wounds with high risk of infection. We believe that patients undergoing surgical resection of a lower limb soft tissue sarcoma treated with preoperative radiation therapy and a primary closure have higher risk of infections and will benefit from the INPWT. We propose a multicenter randomized clinical trial where patients will be randomized to either the Incisional Negative Pressure Wound Therapy or the conventional dressing, which is the current standard of care. The primary outcome is major wound complications within 120 days of surgery. Analysis of data will be completed using intention to treat principles. Secondary outcomes include length of stay in hospital, local tumor control, metastatic failure, overall survival, duration of home care requirements, cost and patient satisfaction. The hypothesis is that sarcoma patients randomized to postoperative care with INPWT will have lower rates of wound complications, decreased hospital length of stay, and improved outcomes compared to patients treated with conventional dressings.