INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. J. Werier
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Incisional Negative Pressure Wound Therapy (INPWT)
Other interventionA 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.
Wound Dressing
Other interventionA 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.
Treatment groups
291 Participants
are divided into 2 treatment groupsGroup A: VAC Wound DressingExperimental treatment 1 intervention
Group B: Control Wound DressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound Complication including re-operation for superficial or deep site infection
* Wound requiring deep wound packing to an area greater than 2cm in length * Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.
Time frame
120 days post opSecondary outcomes
1
patient satisfaction
Patient satisfaction will be evaluated by validated questionnaires.
Time frame
All within this 120 day post-op2
Functional outcome
Secondary outcomes include length of stay in hospital,
Time frame
120 days postop3
Overall cost
A cost analysis will be performed by evaluating the average inpatient cost per day, number of emergency department and clinic visits, cost of secondary procedures cost of INPWT and cost of home care visits.
Time frame
120 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. J. Werier
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
Source ClinicalTrials.gov