Composition and Origin

• Material: DemeTech's Silk suture is made from fibroin, an organic protein.
• Source: The raw material for silk is derived from the cocoon produced by the silkworm larva.

Processing and Characteristics

• Natural Waxes and Gums: Before being used for sutures, the natural waxes and gums of silk are removed. This process ensures a tight, compact braid, enhancing the suture's quality.
• Visibility: The silk suture is dyed black to enhance its visibility during surgical procedures.
• Nature: DemeTech's Silk suture is non-absorbable and multifilament, which means it is made of multiple threads twisted together.

Tissue Reaction and Durability

• Inflammatory Reaction: Being a natural fiber, silk does initiate an acute inflammatory reaction when placed in tissue.
• Encapsulation: Post the inflammatory response, the suture gets gradually encapsulated by fibrous connective tissue, typically within 14-21 days.
• Tensile Strength: Although classified as non-absorbable, the suture experiences a progressive degradation over time. Most of its tensile strength diminishes within the first year of placement.

Key Points

• Natural Origin: The suture's base, silk, comes from a natural source, making it distinct from synthetic suture materials.
• Processing: The removal of natural waxes and gums is a critical step in preparing the suture, ensuring its quality and functionality.
• Tissue Response: Being organic, silk sutures do elicit a tissue response, which is a factor to consider during its application.

Conclusion

DemeTech’s Silk suture offers a unique blend of natural origin and meticulous processing. While it provides the required support during the initial stages of wound healing, its gradual loss of strength over time makes it suitable for specific surgical applications where long-term tensile strength isn't a primary concern. Proper understanding and application of this suture can leverage its benefits while mitigating potential tissue reactions.

Composition and Reaction

• Material: DemeTECH's Silk Nonabsorbable Suture is made from proteinaceous silk fiber.
• Tissue Response: Upon implantation, this suture triggers an acute inflammatory reaction in the tissues.
• Encapsulation: Following the inflammatory response, the body's natural response is to gradually encapsulate the suture with fibrous connective tissue.

Durability and Degradation

• Absorption: Despite its classification as "nonabsorbable," the suture is not retained indefinitely within the body.
• Degradation: The proteinaceous nature of the silk fiber means it undergoes progressive degradation when inside the body.
• Tensile Strength: Over time, specifically within a year of its placement, the suture is expected to lose all of its tensile strength due to this degradation.

Availability and Packaging

• Variety: The suture is available in different sizes, catering to various surgical needs.
• Packaging: It is provided in a sterile condition, with lengths that are either pre-cut or attached to different types of surgical needles, both straight and curved.
• Quantity: Typically, these sutures are supplied in cartons containing one dozen units.

Conclusion

DemeTECH's Silk Nonabsorbable Suture offers a balance between the natural properties of silk and the requirements of surgical applications. While it provides initial wound support, its inherent degradation over time should be taken into account when considering its use for specific surgical procedures. Proper selection and application can maximize its benefits and ensure optimal patient outcomes.

Intended Use

DemeTECH's Silk Nonabsorbable Suture, available both with and without needles, is designed for general soft tissue approximation and/or ligation. It's also suitable for ophthalmic procedures. This product is made for long-term usage, extending beyond 30 days.

Warnings

• Resterilization: It's imperative not to re-sterilize. Any sutures left unused in an opened package should be discarded.
• Calculus Formation: Extended contact with salt solutions, like those in the urinary or biliary tracts, might lead to stone formation.
• Expertise: Surgeons and medical practitioners should be well-versed in surgical procedures involving nonabsorbable sutures before using this product.
• Bacterial Contamination: Using any foreign material alongside bacterial contamination might increase the risk of bacterial infections. Proper surgical protocol should always be followed.
• Reuse: The sutures are designed for single-use. Reusing can pose risks of cross-contamination, compromising both the device's safety and efficacy.

Precautions

• Handling: It's crucial to handle this suture with care to prevent any damage.
• Avoid Damage: Surgical instruments, like forceps or needle holders, should be used judiciously to prevent crushing or crimping the suture.
• Knot Security: Proper surgical techniques should be adopted to ensure the suture knots remain secure.

Adverse Reactions

Patients might experience:

• Wound not healing properly (dehiscence).
• Gradual reduction in the suture's tensile strength.
• Allergic reactions, especially in those allergic to silk.
• Stone formation in the urinary and biliary tracts upon prolonged contact with certain salt solutions.
• Increased bacterial infections.
• Acute inflammatory reactions.
• Symptoms like pain, swelling (edema), and redness (erythema) at the wound site.

Delivery Form

DemeTECH's Silk Nonabsorbable Suture is available in multiple sizes. The sutures come in a sterile form, either pre-cut or attached to various needle types. These needles can be straight or curved. The sutures are typically packaged in cartons containing a dozen units.

In Conclusion

DemeTECH's Silk Nonabsorbable Suture offers surgeons a reliable option for tissue approximation and ligation. However, it's essential to understand the product's intended use, potential risks, precautions, and adverse reactions to ensure the best patient outcomes.