DemeQUICK Sutures

DemeQUICK (Rapid Absorbable) Surgical Suture is a coated, braided synthetic absorbable suture, composed of copolymers made from 90% glycolide and 10% L-lactide. DemeQUICK (Rapid Absorbable) Surgical Suture is coated with a copolymer made from glycolide L-lactide and calcium stearate, it is available colorless or violet from sizes: USP 6-0 to USP 2.

DemeQUICK (Rapid Absorbable) Surgical Suture is indicated for use in superficial soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.

DemeQUICK (Rapid Absorbable) Surgical Suture 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 DemeQUICK (Rapid Absorbable) Surgical Suture occurs by means of hydrolysis, where the copolymer degrades to 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. Implantation studies indicate that DemeQUICK (Rapid Absorbable) Surgical Suture absorption is essentially complete in approximately 40 days.

DemeTech’s Rapid Absorbable suture is a synthetic, absorbable, sterile, surgical suture composed of copolymers made from 90% glycolide and 10% L-lactide. DemeTech’s Rapid Absorbable has been found to be nonantigenic, eliciting only minimal tissue reactivity during the absorption process. Due to a lower molecular weight, relative to DemeTech’s PGA or Polyglactin 910, DemeTech’s Rapid Absorbable is able to achieve a faster absorption period than other synthetic absorbable sutures. The absorption time for Rapid Absorbable is 42 to 56 days. DemeTech’s Rapid Absorbable sutures are available violet and colorless. DemeTech’s Rapid Absorbable sutures give the best characteristics of both natural and synthetic sutures, allowing for the low infection rate of a synthetic suture, while providing the quick absorption and high tensile strength of collagen sutures (catguts). Rapid Absorbable is coated to allow for smooth passage through tissue. Clinical trials have shown that after 5 days post implantation, 50% of DemeTech’s Rapid absorbable initial strength remained. At 10-14 days post implantation, approximately 0% of DemeTech’s Rapid Absorbable linear tensile strength remained.

• Do not re-sterilize. Contents are sterile unless packaging has been opened or damaged. • 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 DemeQUICK (Rapid Absorbable) Surgical Suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. • Acceptable surgical procedure must be followed with respect to drainage and closure of contaminated or infected wounds. • The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing. The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support. • Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury. Discard used needles in ‘Sharps’ containers. • 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.

• 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. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with absorption. • When 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. • DemeQUICK (Rapid Absorbable) Surgical Suture knots must be properly placed to be secure. Adequate knot security requires the accepted surgical technique of flat and 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. • To avoid damaging needle points and swage areas, the needle, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in “sharps” containers. • Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion and delayed absorption may occur. • Avoid prolonged exposure to elevated temperature.