KeragelT®

Healing by Design



KeragelT® is a low-viscosity hydrogel enriched with medical-grade keratin protein that delivers Replicine™ Bioactive Keratin to the wound while maintaining a moisture rich environment. KeragelT® is designed to be easy to apply to delicate skin. KeragelT® is indicated for acute/chronic superficial and partial thickness wounds with dry-to-medium exudate, such as1:

  • Venous leg ulcers
  • Arterial ulcers
  • Diabetic ulcers
  • Pressure ulcers
  • Skin graft donor sites
  • First- and second-degree burns and sunburns

KeragelT® has been shown to be effective in the regular management of injured and uninjured skin of people with various forms of the condition Epidermolysis Bullosa (EB).2-5 EB is a rare genetic connective tissue disorder that affects 1 out of every 20,000 births in the United States.6 It is characterized by extremely fragile skin and recurrent blister formation.
See our clinical trial data in EB patients.

EB results from a genetic mutation in at least one of 18 genes involved with proteins in the epidermis, dermis, or basement membrane.7 These proteins form the major component of the anchoring fibrils, providing support between dermis and basal lamina.4

People with Recessive Dystrophic EB, a major subtype and the most severe form of EB, have insufficient or dysfunctional structural collagen VII protein. Their skin is weak and demonstrates poor adhesion of the epidermis to the dermis. They are therefore susceptible to resultant blistering from minor mechanical friction or trauma, poor skin durability, and slow healing.4

The fact is, EB is highly problematic to treat, and treatment options are limited. Wound products that are atraumatic when applied to normal skin can be damaging to the skin of those affected by EB.3


KeragelT® Is Especially Beneficial For EB

The mechanism and use of KeragelT® in the treatment of EB is supported by data from multiple clinical studies.2-5 In addition, the coating of KeragelT® keeps the nerve endings moist. This aids healing and also keeps air off the wound, which can help with pain that this might normally cause. It can also reduce itch and the subsequent damage that would occur from scratching, especially in EB patients.3,8


KeragelT® Delivers Real Benefits in EB Wound Management

With regular use of KeragelT®, many families, their care givers, and dermatologists have reported benefits in the management of acute wounds, chronic wounds, and uninjured skin for children and adults suffering from a variety of forms of EB. With regular use, EB patients using KeragelT® have reported2-5:

  • More rapid healing wounds3,4
  • Reduced blister frequency4,5,9

Molecular Biologicals is committed to helping the entire EB community around the world by bringing real relief to EB sufferers.


If you are treating or have treated EB patients, please contact us to request product samples and speak with our customer service team about how we can help. Phone  1-844-793-9933

 

See Prescribing Information here.


SAFETY 3

DOSAGE1

INSTRUCTION FOR USE1

No adverse events have been reported. Available in:

– 5gm tube, NDC 71474-302-05
– 20gm tube, NDC 71474-302-20

1. Cleanse and debride the wound in accordance with normal procedures.
2. Ensure that the skin surrounding the wound is dry.
3. To open the tube, use the piercer cap to break the nozzle seal. To ensure sterility, sanitize the piercer cap before use.
4. Apply a 3mm to 6mm (1/8 inch to ¼ inch) layer of KeragelT® to cover the entire wound surface daily or three times a day as indicated by a healthcare professional.
5. Cover with an appropriate secondary dressing if needed.


RECOMMENDED CARE1

The wound should be inspected daily or as indicated by a physician. For wounds that appear dry, more gel should be applied to the area.

Click here for KeragelT® User’s Guide


References

1.KeragelT® [package insert.] Molecular Biologicals: Pasadena, TX; 2017. 2. Tadini G, Marsh C, Kirsner R. An evaluation of a keratin gel to accelerate healing and improve care for epidermolysis bullosa patients. Poster presented at: Symposium on Advanced Wound Care, San Antonio, TX; April 2015. 3. Denyer J, Marsh C, Kirsner RS. Keratin gel in the management of Epidermolysis bullosa. J Wound Care. 2015;24(10):446-450. 4. Kirsner RS, Cassidy S, Marsh C, et al. Use of a keratin-based wound dressing in the management of wounds in a patient with recessive dystrophic epidermolysis bullosa. Adv Skin Wound Care. 2012;25(9):400-403. 5.Than MP, Smith RA, Cassidy S, et al. Use of a keratin-based hydrogel in the management of recessive dystrophic epidermolysis bullosa. J Derm Treat. 2013;24(4):290-291. 6.DEBRA of America. http://www.debra.org/understanding. Accessed August 2, 2018. 7.Lucky, AW, Koplen B, Kelley-Mancuso G. National Organization for Rare Disorders (NORD). Accessed August 17, 2018. 8.Sussman G. Advances in wound dressing technology. Wounds Int. 2013;4(4):12-14. 9.Tang L, Sierra JO, Kelly R, et al. Wool-derived keratin stimulates human keratinocyte migration and types IV and VII collagen expression. Exper Derm. 2012(21):456-476.