SERAMON non-absorbable colorless (5/0) DS-15 needle 50 CM box of 24 sutures - Serag & Wiessner (MEO101713) - Delynov

What is the SERAMON non-resorbable colorless (5/0) suture?

SERAMON, manufactured by Serag-Wiessner, is a synthetic monofilament and non-resorbable surgical suture material. Its composition is based exclusively on polytetrafluoroethylene (PTFE), a polymer recognized for its biological inertness. This colorless suture thread is specifically designed without dyes to meet the needs for discretion and biocompatibility. Packaged in boxes of 24 units, each suture has a length of 50cm and a USP 5/0 calibre. Its monofilament structure prevents bacterial capillarity, thereby limiting the risks of plaque accumulation along the thread, which is crucial for the health of surrounding tissues during the post-operative phase.

What are the clinical indications for SERAMON?

According to the specifications of the manufacturer Serag-Wiessner GmbH & Co. KG, this 5/0 suture is indicated for soft tissue adaptation and performing ligatures when a non-resorbable material is required. Although its use is validated for the circulatory system and the central nervous system, its physical properties make it particularly suitable for surgeries where dimensional stability is necessary. In clinical practice, PTFE threads can also serve as support threads or as a means of marking. It is important to note that current experience is deemed insufficient by the manufacturer for specific use in microsurgery, ophthalmology, or for procedures on peripheral nerves.

What are the technical characteristics of the DS-15 needle?

This reference MEO101713 is equipped with a DS-15 needle. The 'DS' code designates a 3/8 circle needle featuring a triangular reverse cutting point. This geometry is ideal for passing through dense tissues without causing accidental tearing, as the cutting edge is located on the convex curvature of the needle. The number '15' indicates a length of 15mm, offering an optimal compromise between maneuverability and precision for sutures in restricted access areas. The needle is designed in high-quality surgical steel to guarantee smooth penetration and resistance to deformation during repeated passes through gingival or connective tissues.

What are the contraindications for the use of this suture?

The use of Serag-Wiessner SERAMON suture is strictly contraindicated in patients with a known allergy to polytetrafluoroethylene (PTFE) or any other component of the device. The manufacturer also specifies that the choice of material must always be guided by clinical experience and appropriate surgical techniques, as requirements vary according to indications. The instructions for use should be consulted before any use to ensure the product's suitability for the patient's clinical condition. No other specific restrictions are mentioned apart from the caution required in fields where documented clinical experience is still insufficient.

How is a non-resorbable suture like SERAMON managed?

SERAMON is a non-resorbable suture, meaning it does not undergo degradation by hydrolysis or enzymatic action. It retains its tensile strength indefinitely within the tissues. For the practitioner, this implies rigorous knot management to ensure the stability of the assembly, as PTFE has a low coefficient of friction. Unlike resorbable sutures, manual removal of the stitches is necessary after the initial healing phase, generally after 7 to 14 days depending on the clinical protocol. Its smooth monofilament nature facilitates removal without trauma to neoformed tissues, avoiding the tissue adherence often observed with braided structures.

Who is the manufacturer and what standards are respected?

The SERAMON suture is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer based in Germany. This medical device is classified as Class III, corresponding to the highest safety requirements for surgical implants. It carries the CE1014 marking, certifying its compliance with current European regulations. Furthermore, the suture materials comply with the requirements of the European Pharmacopoeia (Ph. Eur.) monograph concerning sterile non-resorbable suture materials (fila non resorbilia sterilia). This compliance guarantees the quality of the materials, the sterility of the product, and the precision of the thread diameters provided to healthcare professionals.

State of the art

Modern synthetic sutures - absorbable or non-absorbable - are central to wound healing in oral surgery. Recent advances focus on reducing post-operative infections.