RecruitingNot ApplicableNCT03175718

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

Sponsor

Dr. J. Werier

Enrollment

291 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of wound dressings — a special negative pressure (suction-based) dressing versus a standard dressing — to see which better prevents wound complications after surgery for soft tissue sarcoma (a type of cancer affecting muscles and connective tissues) in the leg. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with soft tissue sarcoma in the lower limb, confirmed by tissue sample - You are scheduled to receive radiation therapy before surgery, followed by limb-sparing surgery - Your surgeon plans to close the wound directly at the time of surgery - You are available for follow-up visits at the treating centre **You may NOT be eligible if...** - You are under 18 years old - You require reconstructive flap surgery to close the wound - You are not able to attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIncisional Negative Pressure Wound Therapy (INPWT)

A 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.

OTHERWound Dressing

A 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.

Locations(2)

The Ottawa Hospital

Ottawa, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

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NCT03175718