Bandgrip vs Traditional Sutures TJA

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Clinical Trial Assessing Post-operative Wound Healing Complications Following Total Joint Arthroplasty When Using Bandgrip Incision Closure Compared to Standard Suture Closure

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Bandgrip Micro-Anchor Wound Closure
* Device: Suture closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female greater than 18 years of age Scheduled to undergo primary total knee or total hip replacement Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule Exclusion Criteria: Prior surgical incision or scar in close proximity of the proposed incision (<2 cm). Local skin conditions such as dermatitis, eczema, or psoriasis. Active or previous infection in the skin or the hip or knee to be operated. Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use Subject has a recent history of bleeding, coagulation and/or clotting disorders Subject has a known allergy to BandGrip material (polycarbonate)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bandgrip Micro-Anchor Skin Closure<br> | Device: Bandgrip Micro-Anchor Wound Closure<br>* 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<br>|
| Active Comparator: Standard of Care wound closure<br>Standard Monocryl suture closure | Device: Suture closure<br>* This treatment gourd will utilize suture closure technique for all layers of the surgical incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |