INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients (VAC)

• ClinicalTrials.gov Identifier: NCT03175718
• Recruitment Status: Recruiting
• First Posted: June 5, 2017
• Last Update Posted: March 2, 2022
• Sponsor: Dr. J. Werier
• Information provided by (Responsible Party): Dr. J. Werier, Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Soft-tissue Sarcoma; Wound Complication	Other: Incisional Negative Pressure Wound Therapy (INPWT); Other: Wound Dressing	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 291 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a Canadian multicenter superiority randomized clinical trial in patients who are scheduled to undergo surgical resection of a soft tissue sarcoma treated with either preoperative or postoperative radiation therapy and a primary closure. The participants are randomized to Incisional Negative Pressure Wound Therapy (Acelity) or conventional gauze dressing; the current standard of care.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The operative team will remain blinded to the dressing until the time of application. Since wound failure requires the need of medical or surgical intervention, primary outcome of this study is not blinded. However, the treatment arm will be blinded to the Research Coordinator/Outcomes Assessor of secondary outcomes including scar assessment, QoL and Functional Assessment.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: February 1, 2022
• Estimated Primary Completion Date: April 29, 2025
• Estimated Study Completion Date: April 28, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: VAC Wound Dressing; Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 7 days of Incisional Negative pressure wound therapy.	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.
Active Comparator: Control Wound Dressing; Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive standard gauze dressing with no negative pressure application.	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.

Outcome Measures

Primary Outcome Measures :

1. Wound Complication including re-operation for superficial or deep site infection [ Time Frame: 120 days post op ]
   • Wound requiring deep wound packing to an area greater than 2cm in length
   • Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.

Secondary Outcome Measures :

1. patient satisfaction [ Time Frame: All within this 120 day post-op ]
   Patient satisfaction will be evaluated by validated questionnaires.
2. Functional outcome [ Time Frame: 120 days postop ]
   Secondary outcomes include length of stay in hospital,
3. Overall cost [ Time Frame: 120 days ]
   A cost analysis will be performed by evaluating the average inpatient cost per day, number of emergency department and clinic visits, cost of secondary procedures cost of INPWT and cost of home care visits.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Yusra K Al-Mosuli; 6137378920 ext 74709; yalmosuli@ohri.ca

Locations

Canada, Ontario

The Ottawa Hospital; Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contact: Yusra Al Mosuli 613-737-8920 ext 74709 yalmosuli@ohri.ca

Canada, Quebec

McGill University Health Center; Recruiting

Montréal, Quebec, Canada

Contact: Yusra Al-mosuli 613-737-8920 yalmosuli@ohri.ca

Sponsors and Collaborators

Dr. J. Werier

Investigators

• Principal Investigator: Joel Werier; Surgeon

More Information

• Responsible Party: Dr. J. Werier, Orthopedic Oncologist Surgeon, Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03175718
• Other Study ID Numbers: 20170154
• First Posted: June 5, 2017
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. J. Werier, Ottawa Hospital Research Institute:

Sarcoma; Wound; Therapy

Additional relevant MeSH terms:

Sarcoma; Wounds and Injuries; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms