HEALINGMESH. Equine Pericardium ONE STEP PROCEDURE PERFORMANCE & SUPPORT FOR THE LONG RUN

Transcription

1 Global suppliers for biologic surgical materials. ONE STEP PROCEDURE Equine Pericardium The native collagen tridimensional structure is fully maintained after processing HEALINGMESH PERFORMANCE & SUPPORT FOR THE LONG RUN Resetting the wound by restoring the physiological healing process

2 Features of the Tissue Matrix Biomimetic surface for cell attachment that Matches the elasticity and stiffness of dermis Provides coverage for underlying structures Replicates dense connective tissue properties Regenerative Modulates the mechanotransduction properties of cells (i.e. produces appropriate ECM and growth factors) Prevents hypertrophic scars or wound contractures Durable Matrix that persists (does not dissolve) until cellular infiltration is adequate Non-immunogenic Degrades without producing inflammatory response One application sufficient (compared with serial application of other dermal matrices) The native collagen tridimensional structure is fully maintained after processing. Effective stabilization Enzyme resistance Terminal sterilization (beta radiation) -6 Effective destruction of all types of pathogens (SAL )

3 Treatment of Diabetic Foot Ulcer with Acellular Equine Pericardium Alberto Cogo Valter Deanesi Rachele Reitano VASCULAR ULCER PATIENT Age: 53, Male Diabetes Type 2 Insulin treated DIAGNOSIS Ulcer location: anterior tibial Cause: surgical deiscence after saphenectomy for by A-C bypass resulted in blister formation with an underlying grade 2 ulceration Pre-op Post-op TREATMENT HealingMesh was applied Other treatment: non-adherent dressing applied and changed weekly Follow-up: weekly follow-up until wound closure OUTCOME 5 weeks-po 1 Year-po Uneventful post-operative course with no swelling or major exudate. Wound closed after 4 weeks post.operative. The use of HealingMesh was successful in treating chronic diabetic leg ulcer.

4 Treatment of Phlebo-lymphaedema Ulcer with Acellular Equine Pericardium Alberto Cogo Valter Deanesi Rachele Reitano Chia Grigolo LYMPHAEDEMA PATIENT Age: 77, Male Phlebo-lymphaedema ulcer Pre-op DIAGNOSIS Ulcer location: distal medial tibia Cause: phlebo-lymphedema 21 days-po TREATMENT HealingMesh was applied Other treatments: non-adherent dressing applied and changed weekly Follow-up: weekly until wound closure OUTCOME 45 days-po Uneventful post-operative course with no swelling or major exudate Wound closed after 45 days post operative. The use of HealingMesh was successful in treating phlebo-lymphaedema ulcers.

5 Treatment of Chronic Lesion of Achillis tendon Nicola Galante Giampietro Bertasi ACHILLIS TENDON PATIENT Age 57, Male DIAGNOSIS Achillis Tendon Rupture TREATMENT End-to-end Suture HealingMesh was placed between the peritenon and tendon to augment the suture OUTCOME Uneventful post-operative course Wound closed after 3 weeks post operative 8 weeks with orthotic support Range of motion exercises 10 to 14 days after the repair At 6 weeks after the repair begun weight bearing exercise MRI at 3 months post-op shows a complete healing of the achillis tendon Fully recovery at 6 months post-op

6 HEALINGMESH APPLICATION REFERENCE GUIDE PRODUCT APPLICATION REFERENCE GUIDE Step 1 To prepare the wound bed, debride non-viable and hyperkeratotic tissue, if needed. Bleeding should be controlled with sterile compression. Step 2 Prepare HealingMesh in accordance as outlined in the Instructions for use. 500 ml of sterile saline are required. Step 3 Using sterile technique, measure and trim HealingMesh to the appropriate size in order to cover the wound. Make certain there is at least a 2-4 mm excess border for adequate fixation.

7 Step 4 HealingMesh is secured to the wound bed utilizing the client s preference of mechanical fixation (This is generally performed with 4-0 nylon suture or surgical staples). It is important to place the sutures or staples in a pattern that maintains intimate contact between the dressing and the wound bed. It is very important to continue to push HealingMesh down onto the wound bed as each stitch is placed to avoid tenting. Tenting occurs because the HealingMesh is tensioned while being sutured and stretches taut off the bed. Step 5 Keep HealingMesh hydrated. Hydrating ointments may be applied directly to Healing Mesh and covered with a secondary or appropriately sized sterile gauze, can be applied to maintain dressing-to-wound contact and help keep the HealingMesh secure. Step 6 Sutures or anchoring devices are removed once adequate healing has been achieved. 1 YEAR p.o

8 Step 7 To maintain a clean and moist wound environment, outer dressing changes should be performed at least every three/four days. Each dressing change is performed in a similar fashion utilizing antibiotic ointment and dressing materials. Careful observation of the wound should be completed to rule out presence of infection. Step 8 An adequately padded outer warp, which may include a compression type bandage, may be applied to help control any lower extremity edema which could inhibit wound healing. POSTOPERATIVE CARE NOTE This is only a suggested protocol. Decision about appropriate care should be made based on the individual healthcare provider s preference, experience and the extent and severity of the patient s wounds.

9 Bibliography Hozibal, Kimberly B., and Dane K. Wukich. 2012, Diabetic foot infections: current concept review. Diabetic Foot Ankle; 3:1-8 Dumville, Jo. C., Sohan Deshpande, Susan O'Meara, and Katharine Speak Foam dressings for healing diabetic foot ulcers (Review). Cochrane Database System Rev; 9:1-46 Gupta, Subhas, Barbara Bates-Jensen, Allen Gabriel, Allen Holloway, Jeffrey Niezgoda, and Dot Weir Differentiating negative pressure wound therapy devices: an illustrative case series. Wounds,; 19(1):1-9 Zamboni, W. A., H. P. Wong, L. L. Stephenson, and M. A. Pfeifer Evaluation for hyperbaric oxygen for diabetic wounds: a prospective study. Undersea Hyperb Med; 24(3): Wainwright, DJ, Bury, SB Acellular Dermal Matrix in the Management of the Burn Patient. Aesthet Surg J; 31(7):13S-23S Wong I, Burns J, Snyder S Arthroscopic GraftJacket Repair of Rotator Cuff Tears. J Shoulder Elbow Surg; 19(2): Wilkins, R Acellular Dermal Graft Augmentation in Quadriceps Tendon Rupture Repair. Curr Orthop Pract, 21(3): Lee, Daniel Achilles Tendon Repair with Acellular Tissue Graft Augmentation in Neglected Ruptures. J Foot Ankle Surg; 46(6): Sbitany, H., Sandeen, S., Amalfi, A., Davenport, M., Langstein, H Acellular Dermis-Assisted Prosthetic Breast Reconstruction versus Complete Submuscular Coverage: A Head-to-Head Comparison of Outcomes. Plast Reconstr Surg; 124: Obermiller JF,Hodde JP,McAlexander CS,Kokini K,Badylak SF. A comparison of suture retention strengths for three biomaterials. Med Sci Monit 2004; 10: PI 1-PI 5. Links Hirooka A,Yoneda M,Wakaitani S,Isaka Y,Hayashida K,Fukushima S,Okamura K. Augmentation with a Gore-Tex patch for repair of large rotator cuff tears that cannot be sutured. J Orthop Sci 2002; 7: Links Good L,Odensten M,Pettersson L,Gillquist J. Failure of a bovine xenograft for reconstruction of the anterior cruciate ligament. Acta Orthop Scand 1989; 60: Links Jarman-Smith ML,Bodamyali T,Stevens C,Howell JA,Horrocks M,Chaudhuri JB. Porcine collagen crosslinking, degradation and its capability for fibroblast adhesion and proliferation. J Mater Sci Mater Med 2004; 15: Links Langdon SE,Chernecky R,Pereira CA,Abdulla D,Lee JM. Biaxial mechanical/structural effects of equibiaxial strain during crosslinking of bovine pericardial xenograft materials. Biomaterials 1999; 20: Sander T. VP Engineering,Pegasus Biologics, personal communication. Sward L,Hughes JS,Amis A,Wallace WA. The strength of surgical repairs of the rotator cuff. A biomechanical study on cadavers. J Bone Joint Surg Br 1992; 74: Links Mura N,O'Driscoll SW,Zobitz ME,Heers G,An KN. Biomechanical effect of patch graft for large rotator cuff tears: A cadaver study. Clin Orthop Relat Res 2003; 415: Links Davis NR,Risen OM,Pringle GA. Stable, nonreducible cross-links of mature collagen. Biochemistry 1975; 14:

10 Order Information: HM-040X050H HM-060X080H HM-070X080H HM-060X120H Pericardium membrane in propylene - oxide alcoholic solution 40X50 mm Pericardium membrane in propylene - oxide alcoholic solution 60X80 mm Pericardium membrane in propylene - oxide alcoholic solution 70X80 mm Pericardium membrane in propylene - oxide alcoholic solution 60X120 mm (OTHER SIZES ON DEMAND)

11 Audio Technologies Biomembrane Drives the regeneration of the connective tissue Adhesive to the connective tissue Resistant to the traction pressure and retention of the suture Double layer it can be used as double layer, not rolled up Safe: 100,000+ devices implanted without complications Shape memory it does not curl in the operating field Source BSE-free (horses are the only BSE-free mammalians)

12 Mediac BV Oldenzaal Netherlands Copyright 2017 MEDIAC & MEDIAC - MEDICAL is a Trade Mark All rights reseved Sep HMB/2.01