Evaluation: Ethicon Stratafix Spiral Monocryl Plus and Stratafix Spiral PGA-PCL—Mid-Term Absorbable, Synthetic, Barbed Sutures

November 8, 2017 | Evaluations & Guidance


  • These sutures are used to join together the opposing edges of a wound or incision.
    • Typical uses:
      • Skin closure and subcuticular closure
      • Plastic surgery
      • OB-GYN
    • Note: The Stratafix Spiral Monocryl product line features Ethicon's “Plus" antibacterial triclosan coating intended to reduce the risk of certain types of surgical site infections (SSIs). ECRI Institute did not perform a bench test to assess the effectiveness of this antibacterial coating as part of this Evaluation; however, our Health Technology Assessment Information Service published a 2016 overview of clinical literature indicating that antibacterial-coated sutures may reduce SSI risk by 26% among patients undergoing surgery compared to non-coated sutures (membership required for access). Ethicon also submitted supporting documentation to us stating that the World Health Organization (WHO), U.S. Centers for Disease Control and Prevention (CDC), American College of Surgeons (ACS), and the Association for Professionals in Infection Control and Epidemiology (APIC) encourage facilities to at least consider the use of antibacterial-coated sutures to reduce the risk of surgical site infection. This use would depend on:
      • Layer of closure (e.g., according to CDC, these sutures may have benefit in overall SSI risk reduction rather than specifically in deep skin layers)
      • Type of surgery (e.g., WHO suggests their use independent of surgery type, whereas ACS only specifies their use in abdominal cases)
  • Major product components:
    • Synthetic thread of varying lengths and diameters that approximate wound or incision edges for healing purposes.
    • Barbs spiraling around the diameter of the suture material along the length of the suture. Ethicon Stratafix devices are available with unidirectional or bidirectional barbs. ECRI Institute only tested Ethicon's unidirectional sutures in the barbed suture category, based on the product that the manufacturer provided.

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