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Collagenase SANTYL Ointment 250 units/gram

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Anderson, K., & Hamm, R. L. (2014). Factors That Impair Wound Healing. The journal of the American College of Clinical Wound Specialists, 4(4), 84–91. doi:10.1016/j.jccw.2014.03.001
Sheehan, P.J., Jones, P.E., Caselli, A., Giurini, J.M., & Veves, A. (2003). 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, 26 6, 1879-82.
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.
French M, Brown A, Van Wart HE. Identification of clostridium histolyticum collagenase hyperreactive sites in type I, II, III collagens: lack of correlation with local triple helical stability. J Protein Chem. 1992;11:83-95.
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Kim M, Hamilton S, Guddat L, Overall C. Plant collagenase: unique collagenolytic activity of cysteine proteases from ginger. Biochim Biophys Acta. 2007;1770:1627-1635.
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Shi et al. Degradation of human collagen isoforms by Clostridium collagenase and the effects of degradation products on cell migration. Int Wound J. 2010; 7: 87-95.
Sheets AR, Demidova-Rice TN, Shi L, Ronfard V, Grover KV, Herman IM (2016) Identification and Characterization of Novel Matrix-Derived Bioactive Peptides: A Role for Collagenase from Santyl® Ointment in Post-Debridement Wound Healing? PLoS ONE 11(7): e0159598.
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.
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.
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.
Data on fi le. CSR 017-101-09-035. Smith & Nephew, Inc. 2017.
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.
Motley, T. A., Caporusso, J. M., Lange, D. L., Eichelkraut, R. A., Cargill, D. I., & Dickerson, J. E., Jr (2018). Clinical Outcomes for Diabetic Foot Ulcers Treated with Clostridial Collagenase Ointment or with a Product Containing Silver. Advances in wound care, 7(10), 339–348. doi:10.1089/wound.2018.0784
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
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.
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.
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.
Milne CT, Ciccarelli AO, Lassy M. A comparison of collagenase to hydrogel dressings in wound debridement. Wounds. 2010;22:270-274.
In accordance with USP standards and guidelines and data on file.
Leaper DJ, Schultz G, Carville K, et al. Extending the TIME concept: what have we learned in the past 10 years? IntWound J. 2012;9(Suppl2):1-19.
Data on file. Smith & Nephew, Inc. 2018.
Lehrman, J, Patel A, Delhougne, J. Health Care Spending in Patients With Stage 3 and Stage 4 Pressure Injuries and Patients With Diabetic Foot Ulcers Treated Early With Clostridial Collagenase Ointment: A Retrospective Data Review. Wounds. 2020;32(8):228–236.
Baum, C.L. and Arpey, C.J. Normal cutaneous wound healing: Clinical correlation with cellular and molecular events. Dermatologic Surgery, 2005; 31: 674-686.
Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot? Diabetes Metab Res Rev. 2000;16(S1):S75-S83.
Driver VR, Fabbi M, Lavery LA, Gibbons G. The costs of diabetic foot: the economic case for the limb salvage team. J Am Podiatr Med Assoc. 2010;100(5):335-341.
Weiss AJ (Truven Health Analytics), Elixhauser A (AHRQ), Steiner C (AHRQ). Readmissions to U.S. Hospitals by Procedure, 2010. HCUP Statistical Brief #154. April 2013. Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb154.pdf.
Collagenase SANTYL Ointment [prescribing information]. Fort Worth, TX: Smith & Nephew, Inc.; 2016.
Enoch S, Harding K. Wound bed preparation: the science behind the removal of barriers to healing. Wounds. 2003;15:213-229.
Shi L, Carson D. Collagenase Santyl ointment: a selective agent for wound debridement. J Wound Ostomy Continence Nurs. 2009;36(6 Suppl):S12-S16. doi:10.1097/WON.0b013e3181bfdd1a
Hansbrough JF, Achauer B, Dawson J et al. Wound healing in partial-thickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. J. Burn Care Rehabil. 16(3 Pt 1), 241–247 (1995).
Ostlie DJ, Juang D, Aguayo P et al. Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial. J. Pediatr. Surg. 47(6), 1204–1207 (2012).
Frye K, Luterman A. Decreased incidence of hypertrophic burn scar formation with the use of collagenase, an enzymatic debriding agent. Wounds 17(12), 332–336 (2005).
Ozcan C, Ergun O, Celik A, Corduk N, Ozok G. Enzymatic debridement of burn wound with collagenase in children with partial-thickness burns. Burns 28(8), 791–794 (2002).
Galperin RC, Lange DL, Ramsay SJ et al. Anti-inflammatory effects of clostridial collagenase results from in vitro and clinical studies. J. Am. Podiatr. Med. Assoc. 105(6), 509–519 (2015).
Carter MJ, Gilligan AM, Waycaster CR, Fife CE. Treating pressure ulcers with clostridial collagenase ointment: results from the US Wound Registry. Wound Repair Regen. 24(5), 904–912 (2016).
McCallon SK, Frilot C. A retrospective study of the effects of clostridial collagenase ointment and negative pressure wound therapy for the treatment of chronic pressure ulcers. Wounds 27(3), 44–53 (2015).
Waycaster C, Milne CT. Clinical and economic benefit of enzymatic debridement of pressure ulcers compared with autolytic debridement with a hydrogel dressing. J. Med. Econ. 16(7), 976–986 (2013).
Carter MJ, Gilligan AM, Waycaster CR, Schaum K, Fife CE. Cost effectiveness of adding clostridial collagenase ointment to selective debridement in individuals with stage IV pressure ulcers. J. Med. Econ. 20(3), 253–265 (2017).
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. 8, 7 (2015).
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Milne CT et al. A comparison of collagenase to hydrogel dressings in maintenance debridement and wound closure. Wounds, 2012; 24(11):317–322.
Waycaster C et al. Pressure ulcer treatment in a long-term care setting: wound bed healing with clostridial collagenase ointment versus hydrogel dressing. Chronic Wound Care Manage Res, 2014; 1: 49–56.
Gilligan AM et al. Comparative effectiveness of clostridial collagenase ointment to medicinal honey for treatment of venous leg ulcers in outpatient care settings. Presented at: 7th Annual SAWC, Sept. 2015; 26–28.
Gilligan AM, Waycaster C, Carter MJ, Fife CE. Collagenase ointment for the treatment of venous leg ulcers in outpatient care settings. Presented at: ISPOR 20th Annual International Meeting, May 2015; 16–20.
Frederick RE, Bearden R, Jovanovic A, Jacobson N, Sood R, Dhall S. Clostridium Collagenase Impact on Zone of Stasis Stabilization and Transition to Healthy Tissue in Burns. Int J Mol Sci. 2021;22(16):8643. Published 2021 Aug 11. doi:10.3390/ijms22168643
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Important Safety Information

Indication: Collagenase SANTYL Ointment (“SANTYL”) is indicated for debriding chronic dermal ulcers and severely burned areas. Contraindications: SANTYL is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase. Warnings and Precautions: The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. As such, the wound should be properly cleansed prior to application of SANTYL. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when SANTYL was not confined to the wound. SANTYL is not indicated for wound closure. Discontinue use of SANTYL after granulation tissue is well-established. Adverse Reactions: No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. The risk information provided herein is not comprehensive. To see the complete Prescribing Information, please see the FDA-approved product labeling, here: https://www.santyl.com/pdf/SANTYL-PI.pdf. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

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