Abstract

The purpose of this report is to describe an expanded suture and needle clinical evaluation program jointly designed by hospital representatives of Consorta, Inc. (Rolling Meadows, Illinois), a leading healthcare resource management and group purchasing organization, and United States Surgical/Davis & Geck Sutures (Division of United States Surgical, Norwalk, Connecticut). In this expanded evaluation program, 42 Consorta shareholder hospitals enrolled 1913 surgeons to participate in Phase II of this non-experimental observational study of the clinical performance of surgical needles and sutures. Performance characteristics of the sutures and needles produced by USS/DG that were evaluated in 25,545 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 these 30-day studies, the surgeons found that the needles and sutures were clinically acceptable in 98.1% of the evaluations. The general, cardiothoracic, and orthopedic surgeons who performed 61.2% of the product evaluations reported that the suture and needle products were clinically acceptable in 98.2% of the evaluations. Nearly half (49.2%) of the evaluations involved the POLYSORB* braided synthetic sutures that received a clinically acceptable rating in 98.2% of the evaluation. The silk suture (SOFSILK*), followed by the monofilament nylon suture (MONOSOF*), were the next most frequently used sutures. The SOFSILK* was found to be clinically acceptable in 99.2% of the evaluations, while MONOSOF* was noted to be clinically acceptable in 98.7% of the evaluations. Surgical needles made by USS/DG Sutures also had a high rating of clinical acceptability (97.9%).

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