Incisional Negative Pressure Wound Therapy (INPWT): A total of 291 patients will be randomized to receive 7 days of Incisional Negative pressure wound dressing. The dressing will be removed 1 week after surgery.
Wound Dressing: A total of 291 patients will be randomized for standard gauze dressing. This dressing requires no pressure and is applied according to the current standard dressing procedures of the institution. The dressing will be changed every 2-3 days.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Wound Complication including re-operation for superficial or deep site infection — 120 days post op * Wound requiring deep wound packing to an area greater than 2cm in length
* Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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