SERAFIT absorbable purple (4/0) needle DSS-15 of 45 CM box of 24 sutures - Serag & Wiessner (6O15131T) - Delynov

What is the SERAFIT violet absorbable suture (4/0)?

SERAFIT from the brand Serag-Wiessner is a Class III medical device designed for surgery. It is a synthetic and multifilament absorbable suture. Its structure is braided to offer excellent handling and optimal knot security. This thread is composed of a polyglycolic acid homopolymer, a material recognized for its biocompatibility. To improve passage through tissues, the thread may be coated with calcium stearate with polycaprolactone or polyglycolic acid. This specific reference features a 4/0 USP calibre, a violet color for increased visibility in the surgical field, and a length of 45cm, packaged in boxes of 24 units by the manufacturer Serag-Wiessner GmbH & Co. KG.

What are the clinical indications for this 4/0 absorbable suture?

This absorbable suture is primarily indicated for the closure of soft tissues and hollow organs. In oral and implant surgery, it is used for flap suturing, graft stabilization, or closure of extraction sites. The 4/0 calibre is particularly suitable for tissues of medium density where tensile strength is necessary during the critical healing phase. The SERAFIT material is designed to be degraded by hydrolysis, which avoids a second intervention for suture removal, thus simplifying post-operative follow-up for the practitioner and the patient. Its use must comply with surgical techniques mastered by the user, taking into account the in-vivo specificities of the material.

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

The DSS-15 needle equipped on this Serag-Wiessner suture possesses specific properties for delicate tissues. The DSS code designates a 3/8 circle needle with an atraumatic reverse cutting triangular point. This geometry is specifically designed to penetrate thin mucous membranes and dense tissues without causing undesirable lateral tearing. The number 15 indicates a body length of 15 mm, offering an ideal compromise between maneuverability in the restricted spaces of the oral cavity and the ability to encompass enough tissue for a secure closure. Its atraumatic design guarantees a smooth passage of the 45cm thread, minimizing tissue trauma during needle passage.

What are the contraindications for the use of SERAFIT?

The use of SERAFIT suture involves strict limits defined by the manufacturer Serag-Wiessner GmbH & Co. KG. It must absolutely not be employed when stability of the suture material is required in a prolonged or long-term manner, as its absorbable nature leads to a programmed loss of mechanical strength. Furthermore, this device is contraindicated in patients with known allergies to any of its components, notably glycolic acid, calcium stearate, or polycaprolactone. It is also advised against using absorbable sutures in tissues with low blood supply, as this can lead to suture extrusion or delayed absorption, compromising healing.

How does the absorption process work and what are the precautions?

The absorption of SERAFIT occurs through a process of hydrolysis within the tissues. This mechanism transforms the polymer into glycolic acid, which is then naturally metabolized by the body. The degradation kinetics take place in two phases: first a reduction in surface tension, then a total loss of mass of the thread. In vitro, the breaking strength loses approximately 60% of its initial value after 14 days. In vivo, total absorption is generally complete after approximately 90 days. Particular caution is required in patients with delayed healing. The practitioner must choose this material based on in-vivo characteristics and the specific requirements of the wound to be sutured.

Who is the manufacturer and what standards are respected?

This suture is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer located in Naila, Germany. The product benefits from the CE1014 marking, guaranteeing its compliance with European safety and performance requirements for medical devices. As a Class III device, it meets the strictest standards for quality control and biocompatibility. Each box of 24 sutures bears the technical reference 6O15131T. Professionals must imperatively read the attached instructions carefully before use to respect the warnings and precautions for use dictated by the manufacturer to ensure maximum safety during surgical interventions.

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.