STACK UP. See how we. Compare Cardinal Health LiquiBand OCTYL Topical Skin Adhesive to other leading products.

Transcription

1 See how we STACK UP Compare Cardinal Health LiquiBand OCTYL Topical to other leading products. Violet octyl adhesive. Expresses adhesive for up to 90 minutes after activation. Blue applicator indicates octyl adhesive inside. Winged applicator helps provide controlled application. Viscosity... 2 Atraumatic topical wound closure... 2 Microbial barrier... 2 Wound closure strength... 3 Tensile strength... 4 Lap shear strength... 5 Set time... 6 Applicator open time... 7 Surface area coverage... 8 Adhesive yield... 8 Featuring LiquiBand OCTYL Topical... 9 Ordering information...10 Indications for use

2 Viscosity 1,2 Atraumatic topical wound closure 2 LiquiBand OCTYL Topical Skin Adhesive delivers viscosity comparable to Dermabond Mini Topical and sloughs off naturally within five to ten days. Helps provide atraumatic wound closure. Low exothermic reaction 1,3 Low Viscosity High An exothermic reaction is a chemical reaction that releases energy by heat. It is desirable to have as little heat as possible to minimize the burning sensation on patient s skin. Low 0 9 cp 2 Medium High cp cp 1 LiquiBand OCTYL Topical has a lower exothermic reaction than Dermabond Advanced Topical and Dermabond Mini Topical. LiquiBand Butyl Topical Skin Adhesive LiquiBand OCTYL Topical Skin Adhesive Dermabond Advanced Topical Dermabond Mini Topical Skin Adhesive Microbial barrier 2 In vitro studies* have shown that Cardinal Health TM LiquiBand OCTYL Topical acts as a protective barrier to microbial penetration as long as the adhesive film remains intact. Comparison of exothermic reactions Max temp increase** ( C) LiquiBand OCTYL Topical Skin Adhesive Dermabond Advanced Topical Dermabond Mini Topical 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 2 Data on file with Advanced Medical Solutions (Plymouth) Ltd. * Microbes tested included S. aureus, P. aeruginosa, E. coli, Candida albicans and MRSA 3 N=13 for Cardinal Health Liquiband OCTYL Topical and Dermabond Mini Topical. N=14 for Dermabond Advanced Topical. Following the manufacturer s instructions for use, all products were applied on a porcine skin substrate. The maximum temperature reached, without taking into account the baseline temperature, during testing was 35.7 C for LiquiBand OCTYL Topical, 48.9 C for Dermabond Advanced Topical and 57.9 C for Dermabond Mini Topical. ** As compared to baseline temperature page 2 of 12

3 Wound closure strength 2,4 Wound closure strength was evaluated following ASTM standardized testing protocol (ASTM F ). Testing showed that there is no significant difference between the wound closure strength of Cardinal Health TM LiquiBand OCTYL Topical and Dermabond Advanced Topical. Wound closure strength measures the adhesion strength of a topical skin adhesive in closing the open wound tissues. The higher the numeric value, the greater the strength. Mean wound closure strength (N) Comparison of 1-layer application*** LiquiBand OCTYL Topical Dermabond Advanced Topical 2 Data on file with Advanced Medical Solutions (Plymouth) Ltd. 4 N = 11 for LiquiBand OCTYL Topical. N = 18 for Dermabond Advanced Topical. Mean wound closure strength data as tested on xenograft. All products were applied following the manufacturer s instruction for use. Testing completed per ASTM F *** LiquiBand OCTYL Topical should be applied very sparingly, along the edges of the wound. Avoid heavy application. Please refer to product IFU for full instructions, risks and warnings. page 3 of 12

4 Tensile strength 1,5 Tensile strength was evaluated following ASTM standardized testing protocol (ASTM F ). Testing demonstrated that LiquiBand OCTYL Topical demonstrated higher tensile strength than Dermabond Advanced Topical. Tensile strength measures the force required to break the skin adhesive under tension. The higher the numeric value, the greater the strength. Comparison of 1-layer application*** 0.10 Mean tension strength (MPa) LiquiBand OCTYL Topical Dermabond Advanced Topical 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 5 N=17 for Dermabond Advanced Topical. N=12 for LiquiBand OCTYL Topical. Mean tensile strength data as tested on porcine skin substrate. All products were applied following the manufacturer s instruction for use. Testing completed per ASTM F *** LiquiBand OCTYL Topical should be applied very sparingly, along the edges of the wound. Avoid heavy application. Please refer to product IFU for full instructions, risks and warnings. page 4 of 12

5 Lap shear strength 1,6 Lap shear strength was evaluated following ASTM standardized testing protocol (ASTM F ). Testing demonstrated that LiquiBand OCTYL Topical demonstrated higher lap shear strength than Dermabond Advanced Topical. Lap shear strength is an indication of the adhesive strength when wounds are subjected to sliding, displacement or shearing movements. The higher the numeric value, the greater the strength. Comparison of 1-layer application*** 0.15 Mean lap shear strength (MPa) LiquiBand OCTYL Topical Dermabond Advanced Topical 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 6 N=18 for Dermabond Advanced Topical and Dermabond Mini Topical. N=16 for LiquiBand OCTYL Topical. Mean lap shear strength data as tested on porcine skin substrate. All products were applied following the manufacturer s instruction for use. Testing completed per ASTM F *** LiquiBand OCTYL Topical should be applied very sparingly, along the edges of the wound. Avoid heavy application. Please refer to product IFU for full instructions, risks and warnings. page 5 of 12

6 Set time 1,7 LiquiBand OCTYL Topical achieved comparable set time to competitors. LiquiBand OCTYL Topical (1-layer): 79 sec. Dermabond Advanced Topical (1-layer): 145 sec. Dermabond Mini Topical (2-layer): 177 sec. :79 :145 :177 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 7 N = 10. Mean set time as tested on porcine skin. Set time is described as when the adhesive is no longer tacky. Where variability of adhesive coat weight was observed, the highest profile was used to determine set time. page 6 of 12

7 Applicator open time 1,2,8 Avoids premature drying or clogging and allows adhesive to be expressed for up to 90 minutes after activation Number of applicators unclogged / usable < <10 Time (min) <10 <5 90 LiquiBand OCTYL Topical Dermabond Advanced Topical Dermabond Mini Topical Innovative dome tip Innovative dome tip helps allow for controlled application. 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 2 Data on file with Advanced Medical Solutions (Plymouth) Ltd. 8 N = 10. Applied to poster board. An applicator was considered to be unclogged if adhesive could still be expressed. All products tested up to 90 minutes. page 7 of 12

8 Surface area coverage 1,9 When compared to Dermabond Advanced Topical Skin Adhesive, LiquiBand OCTYL Topical Skin Adhesive offered the higher level of surface area coverage. Comparison of 1-layer application*** Average total surface area that could be dispensed (cm 2 ) LiquiBand OCTYL Topical 0.8mL volume fill 104 Dermabond Advanced Topical 0.7mL volume fill cm Adhesive yield 1,10 LiquiBand OCTYL Topical Skin Adhesive was shown, on average, to apply a linear line of adhesive longer than Dermabond Advanced Topical. 0.8mL volume fill Provides one of the highest volume fill topical skin adhesives in the industry today Delivers adequate adhesive to cover long incisions Comparison of 1-layer application*** LiquiBand OCTYL Topical 0.8mL volume fill Dermabond Advanced Topical 0.7mL volume fill Adhesive Yield Length (cm) 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical by Cardinal Health (manufactured by Advanced Medical Solutions). 9 N = 10. Following manufacturers instructions for use, the 1-layer adhesive products were applied on porcine skin substrate in a given surface area. Surface area coverage is described as the calculated surface area that could be achieved, taking into account applicator weight and adhesive yield. 10 N = 10. Following manufacturers instructions for use, adhesive was applied in a linear matter on a paper-based substrate until the applicator became clogged or the dispenser was exhausted. Adhesive yield is described as the total linear length measured using this method. *** LiquiBand OCTYL Topical should be applied very sparingly, along the edges of the wound. Avoid heavy application. Please refer to product IFU for full instructions, risks and warnings. page 8 of 12

9 Introducing Cardinal Health LiquiBand OCTYL Topical The newest addition to the LiquiBand Family of topical skin adhesives includes a high-strength 2-octyl cyanoacrylate formula in the signature LiquiBand Winged Applicator. This combination creates an intuitive platform for effective wound closure. 2-octyl cyanoacrylate formula Delivers viscosity comparable to Dermabond Mini Topical and sloughs off naturally within five to ten days. 1,2 Forms protective film over wound site Helps provide durable and flexible coverage over the incision Intuitive, user-friendly winged applicator Ready to use out of the box Helps provide control throughout application 1 Testing conducted by an independent third-party laboratory April-July Results reported are per bench top testing, and cannot be directly correlated to expected clinical results. Results often vary by clinician application and weight of adhesive applied. Unless otherwise noted, all test methods are proprietary. Data on file at Cardinal Health. Products tested included: Dermabond Advanced Topical by Ethicon, Dermabond Mini Topical by Ethicon, and LiquiBand OCTYL Topical Skin Adhesive by Cardinal Health (manufactured by Advanced Medical Solutions). 2 Data on file with Advanced Medical Solutions (Plymouth) Ltd. page 9 of 12

10 Going the distance to provide safe, secure and effective wound closure. Ordering information: Cat. no. Description Fill volume Packaging CHLOT01-08 LiquiBand OCTYL Topical, dome tip, tinted, sterile 0.8mL 10/bx, 6bx/cs To place an order, or for more information, please contact your Cardinal Health sales representative, call customer service at or visit cardinalhealth.com. page 10 of 12

11 Indications for use 11 LiquiBand OCTYL Topical is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand OCTYL Topical may be used in conjunction with, but not in place of, deep dermal stitches. Contraindications Do not use on any wounds with evidence of active microbial, bacterial or fungal infections or gangrene. Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids. Do not use on patients who have a hypersensitivity to cyanoacrylates or formaldehyde. Do not apply internally, inject intravascularly or ingest. Do not use on decubitus ulcers, animal or human bite wounds, or stab wounds. Warnings LiquiBand OCTYL Topical is a fast setting adhesive capable of adhering to most body tissues and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, surface and/or equipment that are not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided. Polymerization of LiquiBand OCTYL Topical may be accelerated by water or fluids containing alcohol: LiquiBand OCTYL Topical should not be applied to wet wounds. LiquiBand OCTYL Topical should not be applied to the eye. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist. When closing facial wounds near the eye using LiquiBand OCTYL Topical, adjust the patient s position so that any flow of the adhesive is away from the eye. The eye should be closed and protected with gauze. Strategic placement of petroleum jelly near the eye can be effective at preventing inadvertent flow of the adhesive into the eye. Use of adhesives near the eye has inadvertently caused some patients eyelids to be sealed shut. In some of these cases, general anesthesia and surgical intervention has been needed to open the eyelid. LiquiBand OCTYL Topical will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where LiquiBand OCTYL Topical Skin Adhesive is intended to adhere. LiquiBand OCTYL Topical is not absorbable and therefore should not be used below the skin as it may cause a foreign body reaction. LiquiBand OCTYL Topical should not be used in areas with high or increased skin tension, such as knuckles, elbows or knees, unless the joint will be immobilized during the skin healing period or the skin tension has been decreased by application of another wound closure device (e.g., sutures or skin staples) prior to application of LiquiBand OCTYL Topical. LiquiBand OCTYL Topical treated wounds should be monitored for signs of infection. Wounds with signs of infection such as erythema, edema, warmth, pain and/or drainage should be evaluated and treated according to standard practice for infection. LiquiBand OCTYL Topical should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction. LiquiBand OCTYL Topical should be used only on wounds that have easily apposed edges which have been thoroughly cleaned, debrided and otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to assure adequate cleansing and debridement. LiquiBand OCTYL Topical should always be applied sparingly, bridging the wound and the aligned wound edges. Avoid pressure on the applicator to prevent wound edge separation, which could cause the topical skin adhesive to be interposed between the wound edges. Application and/or migration (leak) of the topical skin adhesive below the surface of the skin between the wound edges may impair the healing process by forming a barrier. LiquiBand OCTYL Topical polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying LiquiBand OCTYL Topical sparingly onto a dry wound, heat is released slowly and the sensation of heat or pain experienced by the patient is minimized. However, if LiquiBand OCTYL Topical is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort. LiquiBand OCTYL Topical is packaged for a single patient use. Discard remaining opened material after each wound closure procedure. DO NOT re-sterilize LiquiBand OCTYL Topical Skin Adhesive or include it in a procedure pack/tray that is to be sterilized prior to use. Exposure of LiquiBand OCTYL Topical after its final manufacture, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam), is known to increase viscosity and may render the product unusable. 11 LiquiBand OCTYL Topical Instructions for Use; ; Folder page 11 of 12

12 Indications for use 11 (continued) Precautions This product is meant for external dermal application only. Safety and effectiveness of LiquiBand OCTYL Topical have not been evaluated for use on wounds of patients with uncontrolled diabetes mellitus, diseases or conditions that are known to interfere with the wound healing process, or a personal or family history of keloid formation or hypertrophic scarring. Safety and effectiveness have not been evaluated on wounds that have been treated with LiquiBand OCTYL Topical and then exposed for prolonged periods of time to direct sunlight and tanning lamps. LiquiBand OCTYL Topical permeability by topical medications or other fluids is not known and has not been studied. Liquid, ointment or cream medications should not be applied to the wound after closure with LiquiBand OCTYL Topical, as these substances may weaken the polymerized film which may allow for wound dehiscence. If unintended bonding of intact skin with LiquiBand OCTYL Topical should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart. LiquiBand OCTYL Topical is a viscous liquid prior to polymerization. To prevent inadvertent flow of LiquiBand OCTYL Topical to unintended areas the wound should be placed in a horizontal position, with LiquiBand OCTYL Topical applied from above. Potential Adverse Effects Clinical use of cyanoacrylate-based topical skin adhesives has suggested that the following adverse events may occur: wound dehiscence; infection; acute inflammation including erythema, edema, and drainage; bonding to unintended tissues such as the eye; thermal discomfort during polymerization; allergic reaction; foreign body reaction; and chronic non-healing of a wound. 11 LiquiBand OCTYL Topical Instructions for Use; ; Folder Featuring LIQUIBAND is a registered trademark of Advanced Medical Solutions (Plymouth) Ltd. DERMABOND and DERMABOND ADVANCED are trademarks of Johnson & Johnson Corporation Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Lit. no. 2PERI (03/2016) page 12 of 12