SERALENE non-absorbable blue (5/0) DS-15 needle of 75 CM box of 24 sutures - Serag & Wiessner (LO103413) - Delynov

What is SERALENE non-resorbable blue (5/0)?

SERALENE by the brand Serag-Wiessner is a synthetic, monofilament, and non-resorbable surgical suture material. Manufactured from polyvinylidene fluoride (PVDF), this thread is distinguished by its single-strand structure which prevents the wicking effect and reduces the risk of infection. This blue monofilament suture thread has a USP 5/0 calibre, particularly suitable for delicate interventions. Its composition complies with the requirements of the European Pharmacopoeia for sterile non-absorbable sutures. It is tinted blue (solvent blue, colour index nº 61568) to provide a clear visual contrast with surrounding tissues, thus facilitating the practitioner's work during the placement and removal of stitches.

What are the clinical indications for this suture?

SERALENE is indicated for soft tissue approximation and performing ligatures requiring a non-resorbable material. In oral and implant surgery, it is used for flap closure or microsurgery procedures. Beyond the oral sphere, its properties allow for use in the central circulatory and nervous systems, as well as in ophthalmology. This implant surgery suture thread can also serve as a support thread or a marking tool. Its versatility makes it a preferred choice for situations where long-term suture stability is required, guaranteeing constant mechanical hold without premature degradation in the physiological environment.

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

The DS-15 needle equipped with this Serag-Wiessner suture has specific properties for 5/0 dental surgery. The 'DS' code indicates a 3/8 circle needle with a reverse cutting triangular tip. This geometry is ideal for passing through dense or fibrous tissues without causing tearing, as the cutting edge is located on the convex curvature. The number '15' corresponds to a length of 15 mm, offering an optimal compromise between maneuverability in restricted access areas and robustness. The associated thread has a length of 75cm, allowing sufficient freedom of movement for several stitches or complex continuous suture techniques.

What are the contraindications for the use of SERALENE?

The use of SERALENE is contraindicated in patients with known hypersensitivity or allergies to polyvinylidene fluoride or the solvent blue dye. As with any foreign body, the manufacturer Serag-Wiessner GmbH & Co. KG specifies that prolonged contact of this device with the biliary or urinary tracts may promote the formation of calculi. It is imperative that the practitioner adapts the choice of suture material according to the specific characteristics of the surgical site and the patient's clinical condition. Adherence to appropriate surgical techniques is essential to minimize risks related to the implantation of a non-resorbable material.

What are the precautions related to its non-resorbable nature?

As a non-resorbable suture, SERALENE 5/0 maintains its structural integrity indefinitely within the body. Unlike nylon-type threads or resorbable sutures that lose their tensile strength, this vinyl fluoride polymer remains stable. This implies that the stitches must be manually removed once healing is achieved, according to the clinical protocol established by the surgeon. During handling, care must be taken not to damage the smooth surface of the monofilament with sharp instruments, which could weaken the thread. The knotting technique must be precise to ensure knot security despite the low friction characteristic of PVDF.

Who is the manufacturer and what standards are met?

This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized company based in Germany. The product benefits from the CE1014 marking, guaranteeing its compliance with European regulatory requirements. It is classified as a Class III device, which corresponds to the strictest level of control for implantable medical devices. Each box contains 24 sterile sutures under the reference LO103413. The manufacturing quality ensures total compliance with the monograph for sterile non-absorbable sutures of the European Pharmacopoeia, thus offering dental surgeons and implantologists reliable material for their daily clinical procedures.

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.