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Study details changed, new Trial Registration process begun for modified protocol
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| Name | Class |
|---|---|
| London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | OTHER |
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The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.
The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital. |
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| Standard Dressing | Active Comparator | This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Surgical Site Infection (SSI) | The post-operative SSI at the abdomen will be determined following the Center for Disease Control (CDC) criteria. This includes one or more of the following: 1. Purulent drainage from the incision, 2. Organisms identified from an aseptically-obtained specimen 3. Superficial incision with one of the following signs or symptoms localized pain or tenderness; localized swelling; erythema; or heat. d. Diagnosis of a superficial incisional SSI by a physician or designee | 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of seroma diagnosis | The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography. | 30 days after operation |
| The rate of hematoma diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya DeLyzer, MD, FRCSC | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.
| 30 days after operation |
| The rate of wound dehiscence | The diagnosis of wound dehiscence will be made by clinical exam. | 30 days after operation |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |