RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

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.

OTHER

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.

Locations (2)

The Ottawa Hospital

Ottawa, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada