DERMABOND® Topical Skin Adhesive

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Presentation transcript:

DERMABOND® Topical Skin Adhesive The Final Layer of Protection

DERMABOND® Adhesive is equivalent to other commercially available skin closure devices, studied effectively from small to long incisions up to 69cm. DERMABOND PLUS SUTURES SUTURE STAPLES STRIPS Closure Strength Equivalent to 4.0 Variety Strongest Weak Microbial barrier Yes Zone of inhibition No Cosmesis Excellent May leave track marks Inconsistent Patient Comfort - showering Can Shower Immediately Not recommended for period of time Not recommended For period of time Ease of Care Simple Complicated Enduit to bacterial colonization Removal Sloughs off naturally May need removal Needs removal Self removal

What is DERMABOND Topical Skin Adhesive? Cyanoacrylates were developed in 1949 1970s - n-butyl-2-cyanoacrylate 1999 - 2-Octyl-Cyanoacrylate (DERMABOND) 1st FDA approved Topical Skin Adhesive Today – over 5 million patients a year are treated with DERMABOND Adhesive DERMABOND Adhesive is a unique technology 2 Octyl cyanoacrylate has the longest carbon side chain for increased flexibility and, increased breaking strength versus butyl cyanoacrylate1 In vivo and In vitro studies demonstrate a proven microbial barrier against bacteria which may cause infection. 24 months shelf life, stores at room temperature a violet, non tattooing dye for easy observation Skin adhesives Cyanoacrylates were first manufactured in 1949. The first adhesives were noted to have extreme inflammatory effects on tissues. n-butyl-2-cyanoacrylate, which was developed in the 1970s, was the first adhesive to have negligible tissue toxicity and good bonding strength, as well as acceptable wound cosmesis. DERMABOND Adhesive (2-Octyl-Cyanoacrylate), the latest in cyanoacrylate technology, has less toxicity and almost four times the strength of n-butyl-2-cyanoacrylate. 1. Quinn, JV Tissue Adhesives in Wound Care, BC Decker 1998. Attached are chapters from the book. © ETHICON, INC. 2009 3

Mechanism of action is a combination of monomer and plasticizers, that polymerizes to form a flexible/pliable adhesive film Sets or cures within 45-90 seconds following final layer Reaches full mechanical strength in 1 min If needed, can be wiped from skin within 10 seconds after application or with a petroleum based product after setting Adhesive film sloughs or falls off wound within 7-10 days as skin re-epithelialize Equivalent to 7 days wound healing strength in 3 minutes1 OCA: 300-500 microns thick compared to other N- Butyls at : <50 microns thick 1. Singer and Hollander, Lacerations in Acute Wounds: An evidence-based guide, p.85 2. DERMABOND adhesive package insert 3

DERMBOND Adhesive has proven strength over n-butyls and n-butyl blends due to it’s unique formulation. This strength is critical for topical wound closure and microbial barrier. Wound Bursting Strength Compliance Analysis

In vivo studies demonstrated DERMABOND Adhesive microbial barrier provides greater protection than sutures alone as well as n-butyls/ n-butyl blend adhesives.

DERMABOND® Adhesive has unique benefits that offer the potential to impact the cost of care. *Health and Economic Outcomes after OB-GYN Surgery: A Comparison of Skin Closure Techniques Susan G. Murrmann, MD1, Jeffrey S. Markowitz, DrPH2, Elane M. Gutterman, PhD2, Glenn Magee, MBA3 1 University of Tennessee, Department of Obstetrics & Gynecology, Memphis, TN 2 Health Data Analytics, Princeton Junction, NJ 3 Ethicon Inc., Somerville, NJ Sutures Staples OCA Sutures, Staples & OCA Overall P Value Significant pairwise comparisons1 Overall P-Value Significant pairwise comparisons2 Hysterectomy Cohort N= 21,201 N=23,441 N=880 N=489 Percent Unadjusted Analysis Adjusted Analysis 2 Infection as reflected by non-prophylactic antibiotic treatment 12.93% 17.51% 11.14% 23.72% <0.0001 1a,3a,4a,5a,6a 1a,3a,5a,6a Unadjusted Means Total costs (dollars) $5862 $6965 $5816 $9434 C-Section Cohort N=102,797 N=50,097 N=2,391 N=272 12.83% 12.76% 9.50% 13.97% 2a,4a $5572 $5594 $5010 $5949 2a,4a,6a 1a,2a,4a,6a *Poster Presentation at 2008 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists, New Orleans, LA, May 3-7, 2008

Physician, Hospital -centered Benefits DERMABOND Adhesive for final skin closure provides benefits for surgeons, nurses, patients, and hospitals. Physician, Hospital -centered Benefits Proven microbial barrier for lasting protection 7 days of wound healing strength in 1 minutes for strong closure and peace of mind No time spent removing staples or sutures Reduces needle stick exposure Increases patient satisfaction Reduced Hospitalization Costs Nurse, Patient -centered Benefits Reduces number of suture set ups Ease of Post Op wound checks Reduces number of wound dressings Shower immediately Excellent Cosmesis “Real World” benefits for use of DERMABOND Adhesive Physician: time savings in many situations Reduce needle stick exposure No followup needed to remove sutures more reassurance Increased patient satisfaction more difficult patients (geri, pedi, bedbound) building practice, marketing Scott GR, Carson, CL, Borah, GL, DERMABOND skin closures for bilaterial reduction mammoplasties: a review of 255 consecutive cases. Plast Reconst Surg.2007;120:1460-1465. © ETHICON, INC. 2009 8

Things to consider for successful outcomes Standard wound management Remove surgical prep solution Ensure hemostasis Precise application technique Thin layers Dry before bandage No petroleum-based products over DERMABOND Adhesive Post surgical ChloraPrep wipe downs ok as long as DERMABOND Adhesive has dried and the area is not vigorously scrubbed Wound management Relieve tension first! Blot all blood Well defined edges Application Technique Apply in a straight line Consistent, linear bead of flow 2 or 3 THIN layers depending on product Keep dome of applicator above surface, allowing meniscus of fluid to contact skin Do not apply any petroleum based product over DERMABOND Adhesive® adhesive © ETHICON, INC. 2009 9