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

Primary Purpose

Soft-tissue Sarcoma, Wound Complication

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Incisional Negative Pressure Wound Therapy (INPWT)
Wound Dressing
Sponsored by
Dr. J. Werier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft-tissue Sarcoma focused on measuring Sarcoma, Wound, Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ottawa HospitalRecruiting
  • McGill University Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VAC Wound Dressing

Control Wound Dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wound Complication including re-operation for superficial or deep site infection
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

patient satisfaction
Patient satisfaction will be evaluated by validated questionnaires.
Functional outcome
Secondary outcomes include length of stay in hospital,
Overall cost
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.

Full Information

First Posted
March 1, 2017
Last Updated
February 10, 2022
Sponsor
Dr. J. Werier
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1. Study Identification

Unique Protocol Identification Number
NCT03175718
Brief Title
INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
Acronym
VAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 29, 2025 (Anticipated)
Study Completion Date
April 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. J. Werier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft-tissue Sarcoma, Wound Complication
Keywords
Sarcoma, Wound, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
291 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VAC Wound Dressing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Wound Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Incisional Negative Pressure Wound Therapy (INPWT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wound Dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound Complication including re-operation for superficial or deep site infection
Description
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.
Time Frame
120 days post op
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
Patient satisfaction will be evaluated by validated questionnaires.
Time Frame
All within this 120 day post-op
Title
Functional outcome
Description
Secondary outcomes include length of stay in hospital,
Time Frame
120 days postop
Title
Overall cost
Description
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.
Time Frame
120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yusra K Al-Mosuli
Phone
6137378920
Ext
74709
Email
yalmosuli@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Werier
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusra Al Mosuli
Phone
613-737-8920
Ext
74709
Email
yalmosuli@ohri.ca
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusra Al-mosuli
Phone
613-737-8920
Email
yalmosuli@ohri.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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