Prescribing Information For patients
SANTYL DirectSM

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References
  1. Collagenase SANTYL Ointment [prescribing information]. Fort Worth, TX: Smith & Nephew; 2016.
  2. Kim M, Hamilton SE, Guddat LW, Overall CM. Plant collagenase: unique collagenolytic activity of cysteine proteases from ginger. Biochim Biophys Acta. 2007;1770:1627-1635.
  3. Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004;28:321-326.
  4. Fife CE, Carter MJ, Walker D, Thomson B. Wound care outcomes and associated cost among patients treated in US outpatient wound centers: data from the US wound registry. Wounds. 2012;24:10-17.
  5. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17:763-771.
  6. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37:651-658.
  7. Järbrink K, Ni G, Sönnergren H, et al. Prevalence and incidence of chronic wounds and related complications: a protocol for a systematic review. Syst Rev. 2016;5:152.
  8. Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res. 2009;37:1528-1542.
  9. Vowden K, Vowden P. Debridement made easy. Wounds UK. November 2011. Available at: http://www.wounds-uk.com/pdf/content_10133.pdf. Accessed May 5, 2017.
  10. Russo CA, Elixhauser A. Hospitalizations Related to Pressure Sores, 2003. HCUP Statistical Brief #3. December 2008. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb3.pdf. Accessed May 4, 2017.
  11. Weiss AJ, Elixhauser A, Steiner C. Readmissions to U.S. Hospitals by Procedure, 2010. HCUP Statistical Brief #154. April 2013. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb154.pdf. Accessed June 7, 2017.
  12. Brem H, Maggi J, Nierman D, et al. High cost of stage IV pressure ulcers. Am J Surg. 2010;200:473-477.
  13. Enoch S, Harding K. Wound bed preparation: the science behind the removal of barriers to healing. Wounds. 2003;15:213-229.
  14. Mandl I. Collagenases and elastases. In: Nord FF, ed. Advances in Enzymology and Related Areas of Molecular Biology. New York, NY: Interscience Publishers, Inc.; 1961:163-264.
  15. Gilligan AM, Waycaster CR, Bizier R, Chu BC, Carter MJ, Fife CE. Comparative effectiveness of clostridial collagenase ointment to medicinal honey for treatment of pressure ulcers. Adv Wound Care (New Rochelle). 2017;6:125-134.
  16. Motley TA, Lange DL, Dickerson JE, Slade HB. Clinical outcomes associated with serial sharp debridement of diabetic foot ulcers with and without clostridial collagenase ointment. Wounds. 2014;26:57-64.
  17. Jimenez JC, Agnew PS, Mayer P, et al. Enzymatic debridement of chronic non-ischemic diabetic foot ulcers: results of a randomized, controlled trial. Wounds. 2017;29:133-139.
  18. Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003;26:1879-1882.
  19. Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB. Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study. Clin Ther. 2013;35:1805-1820.
  20. Milne CT, Ciccarelli AO, Lassy M. A comparison of collagenase to hydrogel dressings in wound debridement. Wounds. 2010;22:270-274.
  21. Jovanovic A, Ermis R, Mewaldt R, Shi L, Carson D. The influence of metal salts, surfactants, and wound care products on enzymatic activity of collagenase, the wound debriding enzyme. Wounds. 2012;24:242-253.
  22. Data on file. Smith & Nephew, Inc. 2015.
  23. Dreyfus J, Delhougne G, James R, Gayle J, Waycaster C. Clostridial collagenase ointment and medicinal honey utilization for pressure ulcers in U.S. Hospitals. J Med Econ. 2018;21:390-397
  24. Mearns ES, Liang M, Limone BL, et al. Economic analysis and budget impact of clostridial collagenase ointment compared with medicinal honey for treatment of pressure ulcers in the US. Clinicoecon Outcomes Res. 2017;9:485-494.
  25. Waycaster C, Carter MJ, Gilligan AM, Mearns ES, Fife CE, Milne CT. Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers. J Comp Eff Res. 2018;7:149-165.
  26. Motley TA, Caporusso JM, Lange DL, et al. Clinical outcomes for diabetic foot ulcers treated with clostridial collagenase ointment or with a product containing silver. April 2018. Available at: https://www.liebertpub.com/doi/pdf/10.1089/wound.2018.0784. Accessed July 27, 2018
  27. Frykberg RG, Banks J. Challenges in the treatment of chronic wounds. Adv Wound Care. 2015;4:560-582.
  28. Data on file. Smith & Nephew, Inc. 2018.
  29. Carter MJ, Gilligan AM, Waycaster CR, et al. Cost-effectiveness of adding clostridial collagenase ointment to selective debridement in individuals with stage IV pressure ulcers. J Med Econ. 2017;20:253-265.
  30. Waycaster C, Milne C. Economic and clinical benefit of collagenase ointment compared with a hydrogel dressing for pressure ulcer debridement in a long-term care setting. Wounds. 2013;25(6):141–147.
  31. Motley TA, Gilligan AM, Lange DL, Waycaster CR, Dickerson JE Jr. Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial. J. Foot Ankle Res 2015;8:7.
Indication

SANTYL Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.

Important Safety Information

Important Safety Information:Use of SANTYL Ointment should be terminated when debridement is complete and granulation tissue is well established.

One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound.

See complete Prescribing Information for more details.
Important Safety Information

Important Safety Information:Use of SANTYL Ointment should be terminated when debridement is complete and granulation tissue is well established.

One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound.