Clinical trial NCT03175718: INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft-tissue Sarcoma
Wound Complication
Keywords: Sarcoma
Wound
Therapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Canadian multicenter superiority randomized clinical trial in patients who are scheduled to undergo surgical resection of a soft tissue sarcoma treated with either preoperative or postoperative radiation therapy and a primary closure. The participants are randomized to Incisional Negative Pressure Wound Therapy (Acelity) or conventional gauze dressing; the current standard of care.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Wound Complication including re-operation for superficial or deep site infection
timeFrame: 120 days post op
Secondary outcomes:
measure: patient satisfaction
timeFrame: All within this 120 day post-op
measure: Functional outcome
timeFrame: 120 days postop
measure: Overall cost
timeFrame: 120 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Surgeon
name: Joel Werier
role: PRINCIPAL_INVESTIGATOR
References: