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

Recruiting now · Not applicable

Conditions studied: Soft-tissue Sarcoma, Wound Complication

In brief

Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed by surgery. These wounds have a very high rate of wound complications and infection (30%), resulting in more surgeries, longer hospital stays and complex nursing care. Previous research shows that negative pressure (vacuum) dressings applied to the incision at the end of surgery can reduce these complications. The Investigator and his team across Canada will perform a clinical trial comparing standard dressings to these vacuum dressings. The results of this study have the potential to immediately improve the quality of life of soft tissue cancer patients. It can also decrease the amount of time required in hospital and reduce the cost to the Canadian healthcare system.

Key facts

Study ID

NCT03175718

Run by

Dr. J. Werier

People needed

291

Starts

2022-02-01

Expected to finish

2028-01-28

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age and older and are able to provide written consent.
• Patients with lower extremity soft tissue sarcoma confirmed by tissue pathology.Each patient must have local cross sectional imaging (CT or MRI) and a staging CT chest.
• Patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery.
• Patients for which a primary closure must be attained at the time of surgery.
• Patient must be available for postoperative follow-up at the treating center.

You may not qualify if…

• Patients who are less than 18 years of age.
• Patients with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans).
• Patients who underwent surgical amputation
• Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts).
• Patients with a life expectancy less than 120 days.
• Patients who have an allergy or sensitivity to adhesive dressings.

Where it is running

• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• McGill University Health Center — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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