NCT03175718

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (estimated)
• Sponsor: Dr. J. Werier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.

Conditions

• Soft-tissue Sarcoma
• Wound Complication

Interventions

Type	Name	Description
OTHER	Incisional 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.
OTHER	Wound 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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2028-01-01
• Completion: 2028-01-28
• First posted: 2017-06-05
• Last updated: 2026-03-02

Locations

2 sites across 1 country: Canada