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Journal of Long-Term Effects of Medical Implants
Syneture™ Stainless STEEL Suture. A Collective Review of Its Performance in Surgical Wound Closure
Legacy Verified Level I Shock Trauma Center Pediatrics and Adults, Legacy Emanual Hospital; and Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System, USA
David B. Drake
Associate Professor of Plastic Surgery & Orthopedic Surgery. University of Virginia Health System PO Box 800376 Charlottesville VA 22908-0376, USA
George T. Rodeheaver
Plastic Surgery Research Program, Department of Plastic Surgery, University of Virginia Health System, Charlottesville, VA, USA
Kathryne L. Winters
Website Manager and Information Specialist, Trauma Specialists, LLP, Legacy Emanuel Hospital, Portland, Oregon, 1917 NE 97th St. Vancouver WA 98665, USA
Jill Amanda Greene
Washington State University, Vancouver, WA, USA
William B. Long III
Trauma Specialists LLP, Legacy Verified Level I Shock Trauma Center for Pediatrics and Adults, Legacy Emmanuel Hospital Portland, OR, USA
L. D. Britt
Chairman, Brickhouse Professor of Surgery. Department of General Surgery, Eastern Virginia Medical School, Hofheimer Hall, 825 Fairfax Avenue, Norfolk VA 235001, USA
Samuel P. Winters
Research Assistant, Vancouver, Washington, USA
Christine C. Scott
Information Specialist, Vancouver, Washington, USA
Kant Y. Lin
Department of Plastic Surgery, University of Virginia Health System, Charlottesville, VA, USA
Syneture™ (division of U.S. Surgical, division of Tyco Healthcare, Norwalk, Connecticut, USA) STEEL sutures are monofilament stainless steel sutures composed of 316L stainless steel conforming to ASTM Standard F138 grade 2 (" Stainless steel bar and wire for surgical implant"). STEEL sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures. Steel sutures are for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure, and skin closure. They are attached to the following types of surgical needles: Roto-Grip™ Needles and SCC Needle. The sutures and needles are packaged in a Mylar™/Tyvek™ outer envelope.
The purposes of this clinical review are two fold. First, we will report the performance of the Syneture™ STEEL suture product in the largest studies of suture performance ever reported in the literature. In addition, we will provide comprehensive information from the surgical literature that highlights the unique benefits of stainless steel sutures for the following wound closure techniques: sternal fixation, abdominal wound repair, inguinal hernia repair, and skin wound closure.
Consorta Inc. (Rolling Meadows, Illinois), a leading healthcare resource management group purchasing organization, and Syneture™, jointly with a clinician task force, designed a reproducible surgical evaluation program for needles and sutures in a large cooperative of healthcare systems. Because of the subjective nature of the more commonly used suture selection techniques, a nonexperimental observational study approach was designed to replace perception of performance characteristics with actual clinical experience. In a report involving 19 Consorta shareholder hospitals, they discussed the preliminary part (Phase I) of a large nonexperimental observational study of the clinical performance of surgical needles and sutures.
Performance characteristics of the sutures and needles produced by Syneture™ that were evaluated in 3407 surgical procedures included packaging/ease of opening, needle strength and sharpness, tissue drag, knot security, tensile strength, clinically acceptable determinations, and clinically unacceptable determinations. In this preliminary study, the surgeons concluded that the needles and sutures were clinically acceptable in 98.1% of the evaluations. Armed with this favorable experience, we wanted to expand this observational study to an entirely new group of shareholder hospitals that had a larger number of participating hospitals (Phase I, 19 hospitals; Phase II, 42 hospitals). This more than doubling of hospital observational base dramatically increased the number of patients and performance evaluations. In the Phase II expanded program involving 42 hospitals, the number of patients (8939) and the number of evaluations (25,545) were more than twofold the preliminary study.
In the phase I multicentric evaluation of Syneture™ surgical sutures, the performance of 9266 sutures was evaluated. Of these performance evaluations, 130 evaluations focused on Syneture™ STEEL sutures. The surgeons were especially pleased by the performance of this suture product, with 129 Syneture™ STEEL products being judged as clinically acceptable in their performance. Only one Syneture™ STEEL suture was judged to be unacceptable in its performance, resulting in a 99.2% acceptability rating.
In the expanded phase II evaluation of Syneture™ suture products, the performance evaluation involved 25,545 surgical suture evaluations. The performance of Syneture™ STEEL sutures was judged in 215 cases. Of these product performance evaluations, 207 were judged to be clinically acceptable in their performance (96.3%). It is important to emphasize that the phase I and phase II observational studies evaluated the performance of other sutures besides monofilament steel sutures. These comprehensive suture and needle performance evaluations included the following additional sutures: Plain Gut, Mild Chromic Gut, Chromic Gut, DEXON™ II, DEXON™ S, MAXON™, BIOSYN™, SOFSILK™, SURGILON™, BRALON™, MONOSOF™, DERMALON™, SURGIDAC™, POLY-SORB™, TI·CRON™, SURGIPRO™, SURGIPRO™ II, NOVAFIL™, VASCUFIL™, and FLEXON™.
Finally, we provide a collective review of the literature that shows the reliable performance of monofilament stainless steel sutures in the following wound closure techniques: sternal fixation, abdominal wound closure, inguinal hernia repair, and skin wound closure.