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.