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
Qualifiers
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
Treatments tested in this trial
- Incisional Negative Pressure Wound Therapy (INPWT)
- Wound Dressing
Treatment groups
291 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dr. J. Werier
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
Source ClinicalTrials.gov