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STRATAFIX™ Knotless Tissue Control Devices
STRATAFIX™ Knotless Tissue Control Devices
A broad portfolio to meet your wound closure needs. Two innovative product families provide versatility and a unique combination of benefits.
STRATAFIX™ Knotless Tissue Control Devices with Plus Antibacterial technology (triclosan) are proven in vivo to kill bacteria on the suture known to be associated with SSIs,1,2,3*+ and provide the wound-holding strength of interrupted suturing.4-13
STRATAFIX™ Spiral Knotless Tissue Control Devices - A broad range of unidirectional and bidirectional devices offer the smooth glide of a traditional suture.5,8-12
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices – the only barbed closure device that provides strong, secure closure appropriate for high-tension areas, such as fascia.4,14-18
Features & Benefits
STRATAFIX™ Symmetric PDS Plus Devices demonstrated superior tissue holding strength compared to interrupted technique with Coated VICRYL®(polyglactin 910) Suture, continuous technique with PDS®||(polydioxanone) Suture, and V-Loc™ 180 wound closure device.4‡‡§
With significantly more points of fixation than traditional sutures, STRATAFIX™ makes it easier to manage tension on every pass, appropriate tension leads to better wound healing, a prerequisite for good cosmesis.19,20 ||
STRATAFIX™ Plus Knotless Tissue Control Devices have been shown in vitro to inhibit bacterial colonisation of the suture for 7 days or more,1,3 for protection against the most common organisms associated with surgical site infections (SSIs)1,3.
*Refers to STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device only.
†Based on retrospective analysis of 5,958 cases from the Premier Perspective® Hospital Database.
‡In an ex vivo model.
§Superior to VICRYL and PDS in fascia. Superior to V-Loc in subcutaneous tissue.
||Conclusions of suture tension and outcomes based on animal model.
¶In a meta-analysis of 21 Randomised Controlled Trials (RCTs), 6462 patients, 95% CI: (14, 40%), P<0.001.
#All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL® Plus Antibacterial [poliglecaprone 25] Suture, Coated VICRYL® Plus Antibacterial [polyglactin 910] Suture, and PDS® Plus Antibacterial [polydioxanone] Suture).
**Meta-analysis only included traditional (non-barbed) sutures.
§§Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant S. aureus (MRSA), Methicillin-resistant S. epidermidis (MRSE), Escherichia coli, Klebsiella pneumoniae.
||||Refers only to STRATAFIX™ Symmetric PDS™ Plus, STRATAFIX™ Spiral PDS™ Plus and STRATAFIX™ Spiral MONOCRYL™ Plus.
- Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457.
- Storch ML, Rothenburger S, Jacinto G. Experimental efficacy study of coated VICRYL plus antibacterial suture in guinea pigs challenged with staphylococcus aureus. Surg Infect (Larchmt). 2004;5(3):281-288.
- Ming X, Rothenburger S, Yang D, In vivo antibacterial efficacy of MONOCRYL plus antibacterial (poliglecaprone 25 with triclosan). Surg Infect (Larchmt). 2007; 8(2):201-207.
- Nonnenmann H. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc.
- Ethicon study 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 stitching patterns. Approved on August 24, 2012.
- Ethicon, Inc. AST-2013-0056 Performance testing of STRATAFIX Symmetric PDS size 2-0 suture device for tissue holding strength with multiple incision defects to measure gapping. Ethicon, Inc.
- Ethicon performance evaluation memo AST-2012-0510. Performance testing of STRATAFIX Symmetric size 2-0 suture device for tissue holding strength with an incision defect to measure gapping. December 3, 2012. Ethicon, Inc.
- Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belko SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
- Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163 167.
- 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.
- Moran ME, Marsh C, Perrotti M. Bidirectional-barbed suture knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
- 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.
- Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.
- Ethicon study AST-2011-0210. Study to evaluate the tissue holding performance at time zero of DOLFIN PDS Plus barbed suture sizes 1 and 2-0 vs dyed PDS II Plus suture sizes 1 and 2-0 in a continuous stitch pattern—Project DOLFIN 11822, version 1. Approved on July 15, 2011. Ethicon, Inc.
- Ethicon study AST-2011-0341. Performance testing of DOLFIN PDS Plus size 3-0 suture—tissue holding 10 cm incision. Approved on August 22, 2011. Ethicon, Inc.
- Ethicon study PSE 09-0204, project number 11822. Exploratory histological and biomechanical evaluation of DOLFIN following closure of the ventral abdominal wall in a porcine model at 7±1 day. Approved on July 7, 2010. Ethicon, Inc.
- Ethicon study PSE 10-0012, project number 11822. Model development: histological and biomechanical evaluation of 3-0 DOLFIN barbed suture prototypes, 3-0 Quill suture, and 3-0 V-loc suture at ±1 days following closure of the ventral abdominal wall in a rabbit model. Approved on August 8, 2011. Ethicon, Inc.
- Performance Testing of STRATAFIX SYMMETRIC PDS Plus size 0 & 1 Devices – Initiation strength in porcine tissue. AST-2013-0603. Ethicon, Inc.
- Burgess LP, Morin GV, Rand M, Vossoughi J, Hollinger JO. Wound healing. Relationship of wound closing tension to scar width in rats. Arch Otolaryngol Head Neck Surg. 1990;116(7):798-802.
- Höer J, Klinge U, Schachtrupp A, Töns C, Schumpelick V. Influence of suture technique on laparotomy wound healing: an experimental study in the rat. Langenbecks Arch Surg. 2001;386(3):218-223.
- de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2017;104(2):e118-e133. doi:10.1002/bjs.10445.
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