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

Dr. J. Werier

Status: Enrolling

Conditions: Wound Complication; Soft-tissue Sarcoma

Treatments: Other: Incisional Negative Pressure Wound Therapy (INPWT); Other: Wound Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03175718

20170154

Details and patient eligibility

About

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.

Full description

This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.

Enrollment: 291 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 2 patient groups

VAC Wound Dressing

Experimental group

Description:

Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 7 days of Incisional Negative pressure wound therapy.

Treatment:

Other: Incisional Negative Pressure Wound Therapy (INPWT)

Control Wound Dressing

Active Comparator group

Description:

Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive standard gauze dressing with no negative pressure application.

Treatment:

Other: Wound Dressing