ALLODERM

AlloDerm® is donated, human dermal tissue that has been decellularized to remove the risk of rejection or inflammation. It is then freeze dried through a patented process that does not damage the crucial elements of the tissue structure (collagens, elastin and proteoglycans) and packaged with a shelf life up to two years. Once AlloDerm is used as a graft or implant, it quickly revascularizes and repopulates with cells naturally remodeling into the patient's own tissue

• What is AlloDerm®?
AlloDerm is donated human tissue that is processed using a patented technique to remove all epidermal and dermal cells while preserving the remaining biological dermal matrix.
To begin, donor tissue is recovered by U.S. Tissue Banks, which follow the guidelines of the American Association of Tissue Banks (AATB) and the FDA. Donors' medical histories are extensively reviewed and blood samples are screened for evidence of hepatitis B and C, HIV-I, HIV-2, HTLV-I, HTLV-II antibodies, and syphilis. LifeCell further examines donor history and tissue to rule out pathogenic contamination. The tissue is then put through a 3-step process that preserves the structural and biological functionality of the dermis.

Process Steps

› Suspensory materials
• Facial slings (supporting bandage)

AlloDerm® works like an autograft
AlloDerm is used as you would an autograft; following transplantation AlloDerm begins to regenerate into the patient's own tissue.

• Compared to an Autograft
Used as an effective alternative to time-consuming and painful autografts.
Bioactive dermal matrix preserves all the elements necessary for revascularization and cellular repopulation.
Simple rehydration results in tissue that is indistinguishable from autograft, with comparable suturability, cut, fold, etc.
Provides excellent esthetic results, serving as a scaffold for epithelial cell migration-allows pigmentation and contour to emulate surrounding tissues.
Increases patient treatment acceptance.
Increases practice productivity.
Unlike autograft, does not contain damaged cells or matrix, and therefore avoids inflammatory reactions

• Thickness Options
When used with a thinner autograft, AlloDerm allows you to achieve a dermal graft thickness of up to 0.020 inches (0.05 cm) for every procedure and thereby achieve better functional outcomes and cosmesis. That means significantly less contracture than thin autograft alone, allowing patients more mobility. It can also mean a better chance at regenerating normal skin characteristics and reduced hypertrophic scarring. Engraftment rates with AlloDerm and a thin autograft are similar to those of thicker split-thickness skin grafts alone. Handling the tissue is easier if it is rolled or folded with the basement membrane side out.
Taking a thinner autograft minimizes donor-site morbidity, reducing the need for wound care by staff and minimizing discomfort for patients. It also reduces donor site complications such as: scarring, blistering, and hypertrophy. This leads to faster healing of the donor site if reharvesting is necessary.

• PREPARATION of ALLODERM
INSTRUCTION

» Before you rehydrate AlloDerm®
The inner pouch that contains the AlloDerm is not sterile. Do not place the package in the sterile field.
Before procedure, aseptically rehydrate AlloDerm in the operating room for at least 10 minutes and no longer than 4 hours before use.
AlloDerm may be aseptically trimmed to the required dimensions before rehydration.
Each AlloDerm sheet is for single-patient use only and is to be applied surgically.

» Rehydrating AlloDerm®
What you need
• 2 sterile dishes (eg, kidney dishes)
• At least 100 ml of rehydration fluid (sterile normal saline or sterile lactated Ringer's solution) per sheet of AlloDerm.
• Sterile thumb forceps without teeth.

› Step 1: Tear open the foil bag at the notch and remove the inner peel pouch containing the AlloDerm tissue. Keep the peel pouch out of the sterile field..
› Step 2: Open the peel pouch and aseptically remove the tissue. Do not remove the backing yet.
› Step 3: Place the tissue in the first dish in the sterile field.
› Step 4: For tissue smaller than 21 cm², fill the dish with at least 50 ml of rehydration fluid per sheet. For tissue larger than 21 cm², use 100 ml of fluid per sheet..
› Step 5: Submerge the tissue completely and soak for a minimum of 5 minutes. (The backing may float away from the tissue.) Using sterile gloves or forceps remove and discard the backing.
› Step 6: Aseptically transfer the tissue to the second dish filled with at least 50 ml of rehydration fluid per graft. Submerge completely and soak for an additional 5 minutes (thicker grafts may take longer).

Note: When AlloDerm is fully rehydrated, it is soft and pliable throughout. At this stage, it is ready for application to the surgical site.

• Distinguishing Dermal Side and Basement Membrane Side
To determine proper orientation once the graft has been rehydrated, add a drop of blood to both sides of the graft and rinse with rehydration solution. The dermal side will have a bloody appearance, whereas the basement membrane side will appear pink. AlloDerm come from complete revascularization, place the dermal side of the graft against vascular tissue in all applications.
• Thicker grafts may take up to 40 minutes to fully rehydrate, so adjust the rehydration time accordingly
• Prewarming the saline to room temperature will help the AlloDerm rehydrate faster; however, do not heat the saline above 37°C
• If not completely rehydrated, AlloDerm will appear to be of uneven thickness
• Animal studies have shown that implanting dry or incompletely rehydrated AlloDerm induces a mild inflammatory response. Because all animal toxicity and efficacy studies have been performed with fully rehydrated AlloDerm, LifeCell cannot guarantee the optimal performance of AlloDerm that is used before complete rehydration.

• Open Surgical Sites:
AlloDerm can be applied to open surgical sites, and primary closure can be obtained over the top of the tissue. When replacing an integumental membrane, orient the tissue with the basement membrane side toward the cavity to reduce adhesions to the underlying tissue.
If primary closure cannot be achieved, orient the tissue with the dermal side against the most vascular surface.
If the tissue is covering an avascular bed, orient the AlloDerm with the dermal side against the underside of the flaps.
When properly rehydrated, the dermal side of AlloDerm will support revascularization, cell repopulation, and wound closure.

• Closed Surgical Sites:
If the surgical site is closed, a pocket or tunnel can be formed by blunt dissection down to the subdermal (or deeper) plane. After inserting an instrument (such as a tendon passer or alligator forceps), grasp and pull AlloDerm into place. Insertion can be made easier by first moistening the tissue by dipping it in saline. It can then be anchored with absorbable sutures as the incision site is closed.
Success with AlloDerm is maximized within a well-vascularized environment. Therefore, standard procedures should be used to minimize trauma and obtain complete hemostasis at the treatment site
A topical antimicrobial agent should be applied to the incision site. If suture infection occurs, treat it with standard therapy. Most wound infections resolve or subside with standard antimicrobial therapy.

• Potential Adverse Reactions:
When applied properly, AlloDerm has been shown to support the migration of host cells from wound margins and surrounding tissue. Conditions that could potentially inhibit integration of AlloDerm include
• Low vascularity of the surrounding tissue
• Local or systemic infection
• Mechanical trauma
• Poor nutrition or poor general medical condition
• Specific or nonspecific immune response to some component of the graft
• Certain antimicrobials

! Caution: If outer foil bag has been perforated or damaged, do not use the enclosed AlloDerm. Loss of inert gas will have caused partial rehydration and oxidation.
If inner peel pouch has been perforated, do not use the enclosed AlloDerm. It may be contaminated even if outer pouch is undamaged.