• We recommend that a high MVTR transparent dressing such as Tegaderm™ (3 M) be used to cover the AutoloGel.
• Do not use dressings that will absorb AutoloGel and prevent it from contacting cells in the wound bed.
• The transparent dressing called OPSITE◊ (Smith and Nephew) has been observed to liquefy AutoloGel.
• AutoloGel contains active proteins that must contact cells in the wound bed so it is important to use products that will not degrade or inhibit proteins

What is the recommended way to dress a wound treated with AutoloGel?
Wounds treated with AutoloGel should be dressed in accordance with the following recommendations:

• Place a barrier cream or protective skin prep on the intact skin around the wound to protect from maceration.
• The N-terface® (Winfield Laboratories, Inc) contact dressing included in the kit may be used as a guide to position the AutoloGel in the right location and can be packed loosely in the wound. Newly growing granulation will not adhere to it causing any tissue disruption upon removal.
• Place a primary dressing over the AutoloGel and N-terface. This can be a moisture vapor permeable transparent dressing such as Tegaderm. Some clinicians write on it; “Do not remove until x date.”
• Place a secondary dressing over the primary dressing. This can be a gauze pads or wrap or foam dressing to absorb any exudate. This can be changed often if it gets soiled, but the primary dressing should be left in place until the next AutoloGel treatment.

How do you keep the AutoloGel in the wound bed when gravity is working to make it flow out of the wound?
Try to position the patient so the wound is facing upward. Use the N-terface dressing as a guide to keep the AutoloGel in the wound. It is preferable to express the AutoloGel directly into the wound from the applicator. If this is not practical because of limited patient mobility or other factors, AutoloGel could be expressed onto the Interface dressing. Once the AutoloGel has “set up” or become more firm, the N-terface dressing can be rotated and placed onto the wound ensuring that AutoloGel directly contacts cells in the wound bed. Using a double layer of N-terface maintains more of the fluid in the dressing rather than losing it by soaking through with a single layer.

In a large wound, does AutoloGel have to fill the entire cavity?
No. It is most important that the AutoloGel directly contacts cells receptors in the bottom or walls of the wound. Establish a contact layer on the wound surface, it is not necessary to fill the wound cavity.

If AutoloGel is applied to cover only the bottom and side surfaces within a wound, what is recommended for filling the open cavity prior to dressing the wound? The N-terface can be used to loosely fill in the open area in the wound while the gel is against the walls.

Since the AutoloGel creates a moist wound environment, how do you protect the intact skin around the open wound?
Place a barrier cream or protective skin prep on the intact skin around the wound to protect from maceration.

Does AutoloGel work better on certain wounds and not others?
Clinicians have reported good response many types of chronic wounds. Effective wound healing does require that comprehensive wound care including management of the underlying disease or etiology be managed to ensure that the repair progress is not impeded. Of note, clinicians have used AutoloGel to improve healing in very difficult chronic wounds  such as debrided collagen vascular disease wounds, and wounds having exposed tendon, bone, and hardware.

What are the minimum patient lab values recommended for AutoloGel treatment?
Patients should have the following minimum lab values:

• hemoglobin  10.5 g/dL
• platelet count 100 x 10⁹/L
• serum albumin level  2.5 g/dL

These values represent the inclusion cut off in a prospective, randomized, controlled trial evaluating AutoloGel. While these values are well below normal, patients none the less experienced wound repair progress during the study. Treating a patient with lab values below these levels has not been systematically evaluated at this time.

What happens if the patient is malnourished?
Patients with albumin below the 3.5 g/dL normal range have been treated by clinicians. While the healing may be slower in the malnourished patient, wound repair has progressed in patients treated with AutoloGel.

What is the recommended dosing regimen for AutoloGel?

The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:
• Removal of necrotic or infected tissue
• Off-loading
• Compression therapy for venous stasis ulcers
• Establishment of adequate blood circulation
• Maintenance of a moist wound environment
• Management of wound infection
• Wound cleansing
• Nutritional support, including blood glucose control for subjects with diabetic ulcers
• Bowel and bladder care for subjects with pressure ulcers at risk for contamination
• Management of underlying disease

How much blood is drawn?
The Instructions for Use provides a chart relating wound size and patient hematocrit to determine the amount of blood that is required to provide a sufficient amount of AutoloGel for treatment. A routine blood draw containing 20 mL of anticoagulated blood typically produces 8 mL of Platelet Rich Plasma for the preparation of AutoloGel. Blood draw volumes can be adjusted to accommodate wounds of varying size.

How many applications does it take for AutoloGel to work?
The clinical trial and clinician’s experience have demonstrated that wound volume reduction should be seen with each application as long as the components of standard care for comprehensive wound management have been addressed.

Can AutoloGel be used on exposed bone, tendon?
Yes, as long as the area has been debrided of necrotic tissue. Data from clinician’s case studies indicate granulation tissue growth over exposed bone and tendon during the wound repair process.

Can AutoloGel be used in sinus tracts, tunneling, or undermining?
Yes, as long as the areas have been aggressively debrided. Because AutoloGel is flowable and the applicator has a blunt tip, it is possible to express the AutoloGel deep into the sinus tracts, tunneling, or undermining. Data from clinician’s case studies support the use of AutoloGel for reducing the volume of sinus tracks, tunneling, and undermining to the point of eradication.

Can AutoloGel be stored for later use?
The AutoloGel formulation cannot be stored for use at a later time. It is custom made for the patient at the time of wound application.

How long is AutoloGel working in the wound?
The AutoloGel formulation contains protein and non protein molecules known to be critical to both initiate and facilitate the natural healing process. Although the half life of the components in AutoloGel will vary, it is important to consider that AutoloGel may drive healing cascades for days or longer.

How does AutoloGel work on malignant wounds?
The AutoloGel formulation contains growth factors and the use of AutoloGel is contraindicated on malignant wounds.

What is a normal course of therapy?
The average length of treatment depends on the wound size, the type of wound, and other co-morbidities. In a prospective, randomized, controlled trial, the average length of time for 100% epithelialization or full closure in diabetic foot ulcers treated with AutoloGel was 6 weeks.

Is it reimbursed?
Coverage and reimbursement varies depending on the type of payer. Additional info on reimbursement.