Comparing vacuum dressings to standard dressings after surgery for soft tissue sarcoma
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
This study is testing if using vacuum dressings instead of standard dressings after surgery can help patients with soft tissue sarcoma heal better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 291 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT03175718 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Incisional Negative Pressure Wound Therapy (INPWT) compared to standard dressings in patients undergoing surgery for lower extremity soft tissue sarcoma after preoperative radiation therapy. A total of 248 patients will be randomly assigned to receive either vacuum dressings or standard dressings post-surgery. The study aims to evaluate differences in wound complications, length of hospital stay, patient quality of life, satisfaction, and functional outcomes over a follow-up period of four months. The trial is being conducted across multiple orthopedic cancer centers in Canada, led by a team from The Ottawa Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed lower extremity soft tissue sarcoma who are eligible for preoperative radiation therapy followed by limb salvage surgery.
Not a fit: Patients with benign diseases, prior radiation to the treatment area, or those who cannot achieve primary closure at the time of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce wound complications and improve the quality of life for patients undergoing surgery for soft tissue sarcoma.
How similar studies have performed: Previous studies have shown that negative pressure dressings can reduce wound complications, suggesting a promising approach in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ottawa, Ontario and 1 other locations
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Joel Werier — Surgeon
- Study coordinator: Yusra K Al-Mosuli
- Email: yalmosuli@ohri.ca
- Phone: 6137378920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.