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

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ClinicalTrials.gov Identifier: NCT03175718
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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: VAC Wound Dressing Other: Wound Dressing Not Applicable

Detailed Description:
This is a Canadian multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centres across Canada. 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 14 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 4 month period to examine for 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 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 two weeks of 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. This trial will not be blinded to any clinical staff involved due to logistical difficulties in blinding postoperative wound dressings involving a NPWT device. The Research Coordinator/Outcomes Assessor conducting the QoL and Functional Assessment components will be blinded to which arm the participant was in.
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 2 weeks of Incisional Negative pressure wound therapy.
Other: VAC Wound Dressing
A total of 291 patients will be randomized to receive 2 weeks of Incisional Negative pressure wound dressing (Acetily®). The sterile dressing will be applied under a continuous pressure of 125mmHg. The dressing will be changed every 2-3 days. For a total duration of 2 weeks.
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 2 weeks of 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. For a total duration of 2 weeks.



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. Quality of Life [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 who have had previous surgery or radiation therapy to the affected area.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175718


Contacts
Contact: Yusra K Al Mosuli 6137378920 ext 74709 yalmosuli@ohri.ca
Contact: Johanna Dobransky 6137378920 ext 78785 jdobransky@ohri.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Joel Werier Surgeon

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03175718     History of Changes
Other Study ID Numbers: form 6235
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
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 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