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Total Knee Arthroplasty
Closure of Layers
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (p-dioxanone.)1 The device contains IRGACARE* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 μg/m.1 STRATAFIX Symmetric PDS Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.1 STRATAFIX Symmetric PDS Plus Device, being absorbable, is not to be used where prolonged (beyond six weeks) approximation of tissue under stress is required and is not to be used in conjunction with prosthetic devices (i.e. heart valves or synthetic grafts.)1 STRATAFIX Symmetric PDS Plus Device should not be used in patients with known allergic reactions to IRGACARE* MP (triclosan.)1
Close Subcutaneous Tissue
STRATAFIX Spiral Knotless Tissue Control Device
STRATAFIX Spiral Knotless Tissue Control Devices provide the wound-holding strength of interrupted suturing, with greater security and efficiency than continuous suturing.2-11 In pre-clinical studies, STRATAFIX Spiral Knotless Tissue Control Devices maintained tissue-edge approximation under tension even after 2 cuts to the device.12
DERMABOND PRINEO Skin Closure System
DERMABOND PRINEO Skin Closure System provides a flexible microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for SSIs.13,† DERMABOND PRINEO Skin Closure System was shown to provide statistically significant greater skin holding strength than skin staples or subcuticular 4-0 MONOCRYL (poliglecaprone 25) suture.14,‡
* Registered Trademark of BASF Group.
† Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecium.
‡ In an ex-vivo study, more load in N was required to create a 3 ±1 mm gap between skin edges approximated with DERMABOND PRINEO System, than with subcuticular 4-0 MONOCRYL Suture or PROXIMATE ETHICON ENDO SURGERY skin staples (p=0.00).
1. Ethicon, Inc. STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device, Instructions For Use.
2. Ethicon, 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. Data on File. May 2015.
3. Ethicon, AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitchingpatterns. Data on File. Aug 2012.
4. Ethicon, AST-2013-0056. Performance Testing of STRATAFIX Symmetric PDSSize2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping. Data onFile. April 2013.
5. Ethicon, AST-2012-0510. Performance Evaluation Memo. Performance Testing of STRATAFIX Symmetric Size 2-0 suture device for Tissue Holding Strength with an Incision Defect toMeasure Gapping. Data on File. Dec 2012.
6. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
7. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
8. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35.
9. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
10. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety,and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95.
11. Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.
12. Ethicon, AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitchingpatterns. Data on File. Aug 2012.
13. Ethicon, Su 06TR071 Study Report for in vitro evaluation of microbial barrier properties of DERMABOND ProTape, December 2006, Data on File.
14. Ethicon, AST-2012-0290: Study to Compare the tissue holding strength of PRINEO skin closure system with conventional wound closure techniques, October 2012, Data on File.