NCT03175718 INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
| NCT ID | NCT03175718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. J. Werier |
| Condition | Soft-tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 291 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 291 participants in total. It began in 2022-02-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Joel Werier
PRINCIPAL INVESTIGATOR
Surgeon
Frequently Asked Questions
Who can join the NCT03175718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft-tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03175718 currently recruiting?
Yes, NCT03175718 is actively recruiting participants. Contact the research team at yalmosuli@ohri.ca for enrollment information.
Where is the NCT03175718 trial being conducted?
This trial is being conducted at Ottawa, Canada, Montreal, Canada.
Who is sponsoring the NCT03175718 clinical trial?
NCT03175718 is sponsored by Dr. J. Werier. The principal investigator is Joel Werier at Surgeon. The trial plans to enroll 291 participants.