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The Effect of Incisional Negative Pressure Wound Therapy on Wound Complications and Outcomes After Lower Extremity Sarcoma Surgery with Preoperative Radiation Therapy
Led by Dr. J. Werier · Updated on 2026-03-02
291
Participants Needed
2
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age and older and able to provide written consent
- Diagnosis of lower extremity soft tissue sarcoma confirmed by tissue pathology
- Local cross-sectional imaging (CT or MRI) and staging CT chest completed
- Eligible for preoperative radiation therapy followed by limb salvage surgery
- Primary wound closure must be attainable at the time of surgery
- Available for postoperative follow-up at the treating center
You will not qualify if you...
- Patients younger than 18 years
- Diagnosis of benign disease or prior radiation to the anatomic region unrelated to current treatment
- Patients who have undergone surgical amputation
- Patients where primary closure was not achieved, including those with free flaps or skin grafts
- Life expectancy less than 120 days
- Allergy or sensitivity to adhesive dressings
Research Team
Y
Yusra K Al-Mosuli
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