Bandgrip vs Traditional Sutures TJA
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bandgrip Micro-Anchor Skin Closure
|
Device: Bandgrip Micro-Anchor Wound Closure
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
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| Active Comparator: Standard of Care wound closure Standard Monocryl suture closure |
Device: Suture closure
This treatment gourd will utilize suture closure technique for all layers of the surgical incision.
|
Outcome Measures
Primary Outcome Measures
- Number of patients with wound healing complications [From time of surgery to 30 days post-op]
All wound-related complication following surgery
Secondary Outcome Measures
- Closure time of surgical wound [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)]
Time (in seconds) that it takes to close the incisional wound during surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is male or female greater than 18 years of age
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Scheduled to undergo primary total knee or total hip replacement
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Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule
Exclusion Criteria:
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Prior surgical incision or scar in close proximity of the proposed incision (<2 cm).
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Local skin conditions such as dermatitis, eczema, or psoriasis.
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Active or previous infection in the skin or the hip or knee to be operated.
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Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
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Subject has a recent history of bleeding, coagulation and/or clotting disorders
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Subject has a known allergy to BandGrip material (polycarbonate)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rothman Orthopaedics | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Center for Innovation and Research Organization
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Bandgrip001