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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC Wound Dressing | Experimental | 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. |
|
| Control Wound Dressing | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional Negative Pressure Wound Therapy (INPWT) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication including re-operation for superficial or deep site infection |
| 120 days post op |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | Patient satisfaction will be evaluated by validated questionnaires. | All within this 120 day post-op |
| Functional outcome | Secondary outcomes include length of stay in hospital, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusra K Al-Mosuli | Contact | 6137378920 | 74709 | yalmosuli@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Joel Werier | Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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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.
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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.
| Wound Dressing | Other | 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. |
|
| 120 days postop |
| 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. | 120 days |
| McGill University Health Center | Recruiting | Montreal | Quebec | Canada |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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