Szarmach Robin R, Livingston Jean, Rodeheaver George T, Thacker John G, Edlich Richard
Consorta, Inc., Catholic Resource Partners, Rolling Meadows, Illinois.
Plastic Surgery Research Program, Department of Plastic Surgery, University of Virginia Health System, Charlottesville, VA, USA.
J Long Term Eff Med Implants. 2017;27(2-4):319-337. doi: 10.1615/JLongTermEffMedImplants.v27.i2-4.140.
This report describes an innovative suture and needle clinical evaluation program jointly designed by hospital representatives of Consorta, Inc., a healthcare resource management and group purchasing organization, and United States Surgical/Davis & Geck Sutures (USS/D&G), manufacturer of surgical biomaterials. Nineteen Consorta shareholder hospitals enrolled 699 surgeons to participate in Phase I of this nonexperimental observational study of the clinical performance of surgical needles and sutures. Performance characteristics of the sutures and needles produced by USS/D&G, which were evaluated in 3407 surgical procedures, included packaging and ease of opening, needle strength and sharpness, tissue drag, knot security, tensile strength, and clinically acceptable and unacceptable determinations. In these 30-day studies, the surgeons concluded that the needles and sutures were clinically acceptable in 98.1% of the evaluations. 6 e general, cardiothoracic, and orthopedic surgeons, who performed 73.8% of the product evaluations, reported that the suture and needle products were clinically acceptable in 97.2% of the evaluations. More than half (50.1%) of the evaluations involved the POLISORB* braided synthetic sutures, which received a clinically acceptable rating in 98.4% of the evaluation. The next most frequently used sutures were the SOFSILK*, followed by the monofilament nylon suture. SOFSILK* was found to be clinically acceptable in 98.7% of the evaluations, whereas the monofilament nylon was noted to be clinically acceptable in 96.3% of the evaluations. Surgical needles made by USS/D&G had a 97.9% clinical acceptability rating.
本报告描述了一项创新的缝线和缝针临床评估项目，该项目由医疗资源管理和集团采购组织Consorta公司的医院代表与外科生物材料制造商美国外科/戴维斯&盖克缝线公司（USS/D&G）联合设计。19家Consorta股东医院招募了699名外科医生参与这项关于手术缝针和缝线临床性能的非实验性观察研究的第一阶段。在3407例外科手术中对USS/D&G生产的缝线和缝针的性能特征进行了评估，包括包装及开封的便利性、针的强度和锋利度、组织拖拽性、结的牢固性、拉伸强度以及临床可接受和不可接受的判定。在这些为期30天的研究中，外科医生得出结论，在98.1%的评估中，缝针和缝线在临床上是可接受的。一般外科、心胸外科和整形外科医生进行了73.8%的产品评估，他们报告称，在97.2%的评估中，缝线和缝针产品在临床上是可接受的。超过一半（50.1%）的评估涉及POLISORB编织合成缝线，在98.4%的评估中该缝线获得了临床可接受评级。其次使用频率最高的缝线是SOFSILK，其次是单丝尼龙缝线。发现SOFSILK*在98.7%的评估中在临床上是可接受的，而单丝尼龙在96.3%的评估中在临床上被认为是可接受的。USS/D&G生产的手术缝针的临床可接受评级为97.9%。
