DemeCAPRONE ™(Poliglecaprone 25) - Absorable Monofilament Suture

Suture Material

DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied violet and colorless. DemeCAPRONE (Poliglecaprone 25) is available in sizes 2 through 6/0.

INTENDED USE

DemeCAPRONE synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

ACTIONS

DemeCAPRONE (POLIGLECAPRONE 25) synthetic absorbable sutures elicit 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 DemeCAPRONE (POLIGLECAPRONE 25) synthetic absorbable sutures occurs by means of hydrolysis. 

Absorption begins as a loss of tensile strength followed by a loss of mass. Absorption is essentially complete in approximately 90 to 120 days.

DemeCAPRONE (POLIGLECAPRONE 25) synthetic absorbable suture is available in sizes 2 through 6/0.

Characteristics

Characteristics of DemeTECH’S Poliglecaprone 25 Sutures:

- Very high tensile strength initially

- Excellent handling properties and high pliability

- Very low incidence of infection and trauma

- Smooth tissue passage

- Reliable absorption

- High in vivo strength retention

WARNINGS:

• 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 the application of surgical instruments such as forceps or needle holders.     

 • DemeCAPRONE (POLIGLECAPRONE 25) 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 circumstances 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.     

 • Broken needles may result in extended or additional surgeries or residual foreign bodies, and inadvertent needle sticks involving contaminated surgical needles can result in the transmission of bloodborne pathogens.

PRECAUTIONS

• 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.     

 • DemeCAPRONE (POLIGLECAPRONE 25) 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.     

 • Broken needles may result in extended or additional surgeries or residual foreign bodies, and inadvertent needle sticks involving contaminated surgical needles can result in the transmission of bloodborne pathogens.

ADVERSE REACTIONS

Adverse effects, which may be associated with the use of this product, include: 

Wound dehiscence. Failure to provide adequate wound support in sites where expansion, stretching, or distention occur. Failure to provide adequate wound support in patients with conditions that may delay wound healing. Localized irritation when skin sutures are left in place greater than 7 days. Calculi formation when prolonged contact with salt solutions occurs. Enhanced bacterial infectivity. Minimal acute inflammatory reaction, and transitory local irritation.

DELIVERY FORM:

DemeCAPRONE synthetic absorbable suture is available in sizes 7-0 through -2,(metric sized 0.5-5) . The suture is supplied.

sterile in pre-cut lengths or on ligating reels, non-needled or attached to various needle types, in one dozen boxes.

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