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Temporary hold on recruitment
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Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision.
Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bandgrip Micro-Anchor Skin Closure | Active Comparator |
| |
| Standard of Care wound closure | Active Comparator | Standard Monocryl suture closure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bandgrip Micro-Anchor Wound Closure | Device | This treatment group will utilize a suture closure technique for the deep dermal layers with Bandgrip being applied to the most superficial layer of the surgical incision |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with wound healing complications | All wound-related complication following surgery | From time of surgery to 30 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Closure time of surgical wound | Time (in seconds) that it takes to close the incisional wound during surgery | Procedure (The time from the first skin pass with the suture needle until the time the last suture knot is tied will be recorded in seconds) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedics | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Suture closure | Device | This treatment gourd will utilize suture closure technique for all layers of the surgical incision. |
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