GRAFTJACKET® Regenerative Tissue Matrix (RTM) for wounds is donated allograft human dermis, aseptically processed to remove cells and freeze-dried to remove moisture while preserving biologic components and structure of the dermal matrix.
• Replaces damaged or missing tissue with 'like' tissue
• Supports cellular repopulation and revascularization by host tissue
• Maintains surface area contact when sutured or stapled in place
• Fenestrated to allow for wound fluid to escape
• Thin sheet for conformability to the wound
• Can be used for superficial or deep wounds
• Preserved tissue scaffold
• Human acellular dermal matrix
• Requires one application in most cases
• Placed in the operating room or outpatient setting
• Two year shelf life
GRAFTJACKET® RTM for wounds provides a scaffold for the body's repair or replacement of damaged or inadequate integument tissue, such as diabetic foot ulcers, venous leg ulcers, pressure ulcers or for other homologous uses of human integument.
Each package of GRAFTJACKET® RTM is intended for use in one patient, on a single occasion.
GRAFTJACKET® RTM is contraindicated for use in any patient who is sensitive to polysorbate 20 or to any of the antibiotics listed on the package.
Processing of the tissue, laboratory testing, and careful donor screening minimize the risks of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, GRAFTJACKET® RTM cannot be 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 GRAFTJACKET® RTM.
DO NOT sterilize GRAFTJACKET® RTM.
DO NOT use GRAFTJACKET® RTM if either the outer foil bag or the inner (Tyvek®) pouch is perforated or torn. A damaged foil bag or inner (Tyvek®) pouch may result in degradation or contamination of the product.
The inner (Tyvek®) pouch that contains the GRAFTJACKET® RTM is NOT STERILE; DO NOT PLACE THE INNER (Tyvek®) POUCH IN THE STERILE FIELD.
Transfer GRAFTJACKET® RTM from packaging aseptically. Do not place either the foil bag or the inner (Tyvek®) pouch in the sterile field. (See INSTRUCTIONS FOR REHYDRATION.)
It is the responsibility of the physician to determine the appropriate size and thickness of GRAFTJACKET® RTM for each application.
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for implanting GRAFTJACKET® RTM as such conditions may compromise successful implantation. Additionally, users should assess the appropriateness of using the GRAFTJACKET® RTM in patients diagnosed with autoimmune connective tissue disease.
It is the responsibility of the health care practitioner to maintain recipient records for the purpose of tracing tissue post-implantation. Patient tracking labels are provided for convenience.
Use of GRAFTJACKET® RTM is limited to specific health professionals (e.g., physicians and/or podiatrists).
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
Prior to rehydration DO NOT BEND because this may cause the GRAFTJACKET® RTM to fracture. DO NOT USE the GRAFTJACKET® RTM if it is broken or cracked.
DO NOT USE the GRAFTJACKET® RTM if prior to rehydration it is not uniformly white to buff in coloration.
DO NOT USE the GRAFTJACKET® RTM if it has discolored or browned areas. Normal rehydration of GRAFTJACKET® RTM is usually accomplished in 10-15 minutes, depending on thickness. If any hair is visible, remove before implantation. Unused or expired product should be discarded according to local institutional requirements.
Potential adverse effects which may result from placement of an implant or graft include, but are not limited to: wound or systemic infection; dehiscence; hypersensitive, allergic or other immune response; sloughing or failure of the graft; and disease transmission.
Adverse outcomes potentially attributed to GRAFTJACKET® RTM must be reported promptly to LifeCell Corporation.
Store at room temperature.
|Assigned HCPCS code||●|
|Shelf life greater than 2 years|
|Shelf life limited|
|Indicated for acute wounds|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds|
|Indicated for third-degree burns|
|Indicated for venous ulcers|
|Contact manufacturer for usage guidelines|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
Normal rehydration of GRAFTJACKET® RTM is usually accomplished in 10-15 minutes, depending on thickness. When preparing to use GRAFTJACKET® RTM in the operating room, the following rehydration procedure should begin early enough to allow for adequate rehydration prior to intended implantation.
Tear open the foil bag at the notch and remove the inner (Tyvek®) pouch.
Keep both the foil bag and inner (Tyvek®) pouch OUT of the sterile field.
Peel open the inner (Tyvek®) pouch and aseptically remove the tissue. Do not peel backing at this point in the process.
Place the tissue in the first dish in the sterile field. Submerge the tissue completely and soak for a minimum of 5 minutes or until the paper backing separates from the GRAFTJACKET® RTM.
Using a sterile gloved hand or forceps, remove and discard the backing once it separates from the tissue. Then, aseptically transfer the tissue to a second bath sufficiently filled with rehydration fluid.
Submerge completely and soak until the tissue is fully rehydrated.
Approximate rehydration time is 5 minutes for the 1st bath and 5-10 minutes for the second bath.
When GRAFTJACKET® RTM is fully rehydrated, it is soft and pliable throughout. At this stage, it is ready for application to the surgical site. GRAFTJACKET® RTM may be aseptically trimmed to required dimensions.
Use GRAFTJACKET® RTM within 4 hours of rehydration. Tips: Keep GRAFTJACKET® RTM fully submerged by weighing it down (e.g., with sterile forceps). Warming saline up to 37°C and using gentle movement of GRAFTJACKET® RTM in the solution speeds the rehydration process. However, do not heat saline above 37°C. When rehydrating multiple pieces, ensure the pieces are not overlapping or clumping together as this may slow the rehydration process. Use multiple bowls for each rinse step, if necessary. If you are having a problem with rehydration, gently wipe/rub both sides of the GRAFTJACKET® RTM, using a sterile gloved hand, to remove any excess cryo-protectant that may be creating a barrier between the GRAFTJACKET® RTM and the rehydration fluid.
Acelity leverages the strengths of Kinetic Concepts and Systagenix Wound Management to provide a trusted and complementary portfolio of advanced wound therapeutics for customers and patients in more than 90 countries worldwide.