The Effect of Incisional Negative Pressure Wound Therapy on Wound Complications and Outcomes After Lower Extremity Sarcoma Surgery with Preoperative Radiation Therapy

What this Trial Is About

Researchers are studying patients with aggressive soft tissue cancers, specifically lower extremity soft tissue sarcoma, who receive radiation therapy followed by surgery. This study evaluates whether using a special vacuum dressing called Incisional Negative Pressure Wound Therapy (INPWT) after surgery can reduce wound complications, infections, and improve clinical outcomes compared to standard wound dressings. The trial is a multi-center, randomized controlled study involving 248 patients across several orthopedic cancer centers in Canada. Patients will be randomly assigned to one of two groups: one group will receive the vacuum dressing for 7 days after limb salvage surgery performed 4 to 6 weeks post-radiation, while the other group will receive a standard gauze dressing changed every 2 to 3 days. Both groups will otherwise receive similar care. The vacuum dressing will be removed one week after surgery. The study team will monitor patients closely over four months following surgery. During the study, researchers will assess wound complications including infections requiring re-operation within 120 days after surgery. They will also evaluate patient satisfaction, functional outcomes, length of hospital stay, and overall costs during this period. Participants will have follow-up visits at their treatment center, with data collected through clinical assessments and patient reports. Ethical approval has been obtained at all sites, and statistical analysis will be conducted to compare the two dressing methods.

INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients