NCT03175718Recruiting
INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
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
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 291 (estimated)
- First submitted
- 1 Mar 2017
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Dr. J. Werier
- Diseases
- Sarcoma
- NCT number
- NCT03175718
What you commit to
- Study type: Interventional
- Planned participants: 291
- From 1 Feb 2022 to the primary completion date, 31 Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients who have an allergy or sensitivity to adhesive dressings.
Age
- Patients who are less than 18 years of age.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.