INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
The Effect of INPWT on Wound Complications and Clinical Outcomes Following Lower Extremity Sarcoma Surgery in Patients Treated With Preoperative Radiation Therapy: A Multicentre Randomized Controlled Trial
Dr. J. Werier
291 participants
Feb 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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.
Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03175718