DemeCRYL™(Polyglactin 910 ) - Absorable Multifilament Suture

Description: 

Suture Material

DemeTECH’s Polyglactin 910 suture is a synthetic absorbable, sterile, surgical suture composed of copolymers made from 90% glycolide and 10% L-lactide. Polyglactin 910 suture is available in violet or colorless from sizes: USP 8-0 to USP 2. 

Polyglactin 910 meets all the requirements established by the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) for Synthetic Absorbable Surgical Sutures (except for an occasional oversize in some gauges).

Intended Use

Polyglactin 910 Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular or neurological tissue.

Actions

A slight tissue inflammation may occur when Polyglactin 910 Sutures are placed in tissue, which is characteristic of foreign body response, which is followed by gradual encapsulation by connective tissue. After which absorption by hydrolysis begins, where the polymer degrades to glycolic acid, which is absorbed by the body.

Polyglactin 910 elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. 

Progressive loss of tensile strength and eventual absorption of Polyglactin 910 synthetic absorbable sutures occurs by means of hydrolysis, where the polymer degrades to either glycolic acid or glycolic and lactic acids which are subsequently absorbed and metabolized by the body. 

Absorption begins as a loss of tensile strength without appreciable loss of mass.

Complete loss of original tensile strength is lost by 5 weeks post implantation. Absorption of Polyglactin 910 absorbable synthetic suture is essentially complete between 56 and 70 days.

Characteristics

DemeTECH’s Polyglactin 910 suture is a synthetic absorbable, sterile, surgical suture composed of copolymers made from 90% glycolide and 10% L-lactide.   

The chemical formula of DemeTECH’s Polyglactin 910 is (C2H2O2)m(C3H4O2)n. Clinical trials have shown that after two weeks, approximately 75% of DemeTECH’s Polyglactin 910 initial strength remained. At four weeks, approximately 25% of DemeTECH’s Polyglactin 910 linear tensile strength remained. 

DemeTECH’s Polyglactin 910 has found to be nonantigenic and eliciting only mild tissue reactivity during the absorption process. DemeTECH’s Polyglactin 910 sutures are available violet and colorless.

 - Polyglactin 910 is coated in order to create a smoother synthetic absorbable suture that will pass through tissue readily.   

Coated Polyglactin 910 sutures facilitate:    

- Easy tissue passage   

- Precise knot placement   

- Smooth tie down   

- A decreased tendency to irritate tissue   

- Greater tensile strength   

- A longer absorption period  

 - After 3 weeks post operation, in clinical trials, DemeTECH’s Polyglactin 910 sutures still maintain approximately 50% of their tensile strength.

Indications

• Do not resterilize. Discard open unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.  • As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.

• Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Polyglactin 910 synthetic absorbable suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.

• Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.

• The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing.

 • As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching, or distention, or which may require additional support.

• Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

Precautions

• When handling Polyglactin 910 Sutures, it is necessary to handle the suture and needle with care, paying particular attention to the needle and avoiding damage being caused by the needle holders.

• The user should have sufficient knowledge and be familiar with absorbable Surgical Sutures and the particular decreasing tensile strength before handling Sutures.

• Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

• Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.

• In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. 

The use of additional throws may be particularly appropriate when knotting monofilaments. Polyglactin 910 is not suitable for elderly or debilitated patients or patients with retarded wound healing. Tissue with poor blood circulation may reject the suture material due to delayed absorption.

More information: https://www.demetech.us/product/sutures/Polyglactin910