INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Soft Tissue Sarcoma
- Wound Complication
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 two weeks of Incisional Negative Pressure Wound Therapy (Acelity) or conventional gauze dressing; the current standard of care.Masking: Double (Participant, Outcomes Assessor)Masking Description: The operative team will remain blinded to the dressing until the time of application. This trial will not be blinded to any clinical staff involved due to logistical difficulties in blinding postoperative wound dressings involving a NPWT device. The Research Coordinator/Outcomes Assessor conducting the QoL and Functional Assessment components will be blinded to which arm the participant was in.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Canadian multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centres across Canada. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therap...
This is a Canadian multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centres across Canada. 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 14 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 4 month period to examine for 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.
Tracking Information
- NCT #
- NCT03175718
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joel Werier Surgeon
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