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PRMOrder@allergan.com

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Medical Information website

REIMBURSEMENT SUPPORT

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AllerganPRM@thepinnaclehealthgroup.com

Optimizing your use of AlloDermTM RTM

The following is a selection of technique pearls to assist you in obtaining the best results with AlloDermTM RTM. They are provided to guide surgical technique to optimize the performance of AlloDermTM RTM and mitigate the risk of complications. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care. Please refer to the Instructions for Use (IFU) for a full list of considerations.1

Choose a topic below to read more:

Adjacent tissue assessment
Ensuring a vascular supply

AlloDermTM RTM requires a vascular supply to revascularize and cell migration to remodel. It should be covered with healthy, viable tissue. To ensure adjacent tissue is viable, note the following: 1,2

Patient considerations

Patient considerations

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting AlloDermTM RTM, as such conditions may compromise successful clinical outcome.1

Assessing
tissue viability

Assessing tissue viability

The surrounding tissue should be carefully assessed for quality and adequate thickness. The vascularization of surrounding tissues should be assessed clinically or with perfusion technology.1

Clinical intervention

Clinical intervention

Portions of the tissue that appear ischemic or necrotic should be addressed. Debride dead skin where necessary.1

Graft apposition Ensuring proper graft apposition

Graft apposition to vascularized skin is essential for cellular migration and/or engraftment of AlloDermTM RTM.1,2 To ensure proper placement, note the following:

Proper orientation

Proper orientation

AlloDermTM RTM has 2 distinct sides—the “dermal” side and the “basement membrane” side. The dermal side should be placed against the most vascular tissue.1

Appropriate tension

Appropiate tension

AlloDermTM RTM should be sized appropriately and sutured in place under appropriate physiological tension. Avoid excessive tension on the overlying skin at the time of closure.1

Minimizing
dead space

Minimizing dead space

Suture AlloDermTM RTM to minimize potential dead space to reduce the risk of fluid accumulation.1

Fluid accumulation Minimizing fluid accumulation

Fluid accumulation impedes graft apposition, thereby preventing cellular migration and revascularization.2
To minimize fluid accumulation, consider the following:

Fluid communication

Fluid communication

Perforations in AlloDermTM RTM were designed to allow fluid to move through the matrix at time of implantation to facilitate tissue ingrowth.3

Fluid mitigation

Fluid mitigation

Potential dead space should be minimized to reduce the risk of fluid accumulation by utilizing techniques such as appropriate graft tension, suturing, and external compression.1

Fluid management

Fluid management

Surgeons may use active closed-suction drains to minimize the risk of fluid accumulation according to current standard-of-care guidelines and institutional protocols for type, placement, and timing of removal.1

LEARN MORE about perforated options designed for fluid communication.

For clinical or medical questions, please contact Medical Support Team

References: 1. AlloDerm SELECTTM and AlloDerm SELECT RESTORETM Regenerative Tissue Matrix Instructions for Use, March 2020. 2. Khansa l, Janis JE. Modern reconstructive techniques for abdominal wall defects after oncologic resection. J Surg Oncol. 2015;111(5):587-598. 3. Data on file, Allergan; Study Report LRD2015-05-002.
ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX INDICATIONS AND IMPORTANT SAFETY INFORMATION  

ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTDTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM available at www.allergan.com/AlloDermIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.433.8871.

ALLODERM SELECTTM Regenerative Tissue Matrix Indications and  Important Safety Information 

ALLODERM SELECTTM Regenerative Tissue Matrix
Indications and Important Safety Information

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM.

To report an adverse reaction, please call Allergan at 1.800.433.8871.