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SANTYL Ointment plus sharp
Mean percent reduction in ulcer area vs silver-based products (2018) Outcomes of sharp debridement with or without SANTYL Ointment (2014) Integrating SANTYL Ointment between sharp debridements (2017)
SANTYL Ointment vs mechanical (wet-to-dry)
Efficacy comparison to wet-to-dry + sharp (2013)
SANTYL Ointment vs autolytic support
Retrospective analysis: efficacy vs medicinal honey (2017) Efficacy comparison to hydrogel dressings Integrating SANTYL Ointment between sharp debridements (2017)
Use of SANTYL Ointment with other wound care products
Testing compatibility with commonly used wound care products (2012)
Cost-effectiveness of SANTYL Ointment
Hospital inpatient/outpatient re-encounters vs medicinal honey (2018) Cost-effectiveness vs medicinal honey in HOPD setting (2017) Comparative cost-effectiveness for chronic dermal ulcers (2017)
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Watch video

2018 Motley Study Roundtable

Four experts discuss clinically meaningful results comparing SANTYL Ointment vs silver products as adjuncts to sharp debridement in diabetic foot ulcers (DFU)

Study overview

Evaluating two common adjuncts to sharp debridement in the treatment of DFUs

  • The SANTYL Ointment group demonstrated a 62% mean reduction from baseline in ulcer area at Week 6, compared to 40% in the silver treatment group (P<0.071)26
  • A secondary endpoint evaluated target ulcer infection rate based on clinical signs and symptoms of infection; all 102 study subjects were considered to be free of infection when enrolled26¶
    • During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment (n=5/51) than in patients treated with silver-based products (n=11/51); (P=0.208)26

Mean percent reduction in ulcer area from baseline at six weeks26

62%

SANTYL Ointment + supportive care* + periodic sharp debridement26†
n=51

(P<0.071)

40%

Silver products‡ + supportive care§ + periodic sharp debridement26†
n=51

* Supportive care in the SANTYL Ointment group included ALLEVYN◊ Foam Dressing, cast padding, and Coban™ or equivalent bandages.

† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

SANTYL Ointment is not indicated for the treatment or prevention of infection.

Study details

Study overview, endpoints, and design

Objective The primary objective was to compare the mean percent change in ulcer area from baseline to the end of the six-week treatment period in subjects receiving a daily application of SANTYL Ointment versus a comparator product containing silver
Primary endpoint Evaluate mean percent change in ulcer area from baseline to the end of the treatment period (Week 6) in each treatment group
Secondary endpoints
  • Incidences of target ulcer infection in each treatment group during the treatment period were based on presence of clinical signs and symptoms of infection
  • Evaluate mean percent change in ulcer area from baseline to the end of the follow-up period (Week 10)
Limitations Small sample size
Study was not blinded

Number of subjects

(with type 1 or 2 diabetes mellitus and an open neuropathic foot ulcer)

102 total patients in two equally sized groups

SANTYL Ointment group; n=51

  • Female 18% | Male 82%
  • Mean age: 56
  • Race: Alaskan native 2%, black 6%, white 92%
  • Ethnicity: Hispanic/Latino 28%, not Hispanic 72%
  • Mean wound area: 1.6cm2

Silver group; n=51

  • Female 29% | Male 71%
  • Mean age: 58
  • Race: Alaskan native 0%, black 6%, white 93%
  • Ethnicity: Hispanic/Latino 31%, not Hispanic 69%
  • Mean wound area: 1.7cm2

Design

(randomized, multicenter, parallel group study)

10-week group study:

Six weeks of treatment, four weeks of follow-up

Two arms:

  • SANTYL Ointment (QD) + supportive care* + periodic sharp debridement†
  • Product containing silver‡ + supportive care§ + periodic sharp debridement†

All patients agreed to wear an appropriate offloading device.

* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban or equivalent bandages.

† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

Study results

Study shows SANTYL Ointment + sharp achieved clinically meaningful results vs silver + sharp26

  • The SANTYL Ointment group demonstrated a 62% mean reduction from baseline in ulcer area at Week 6, compared to 40% in the silver treatment group (P<0.071)26
  • A secondary endpoint evaluated target ulcer infection rate based on clinical signs and symptoms of infection; all 102 study subjects were considered to be free of infection when enrolled26¶
    • During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment (n=5/51) than in patients treated with silver-based products (n=11/51); (P=0.208)26

* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban or equivalent bandages.

† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

SANTYL Ointment is not indicated for the treatment or prevention of infection.

Debridement and bioburden management

Chronic wounds are typically stuck in the inflammatory phase of healing and are at a higher risk of infection.13

When infection is present in a wound, necrotic tissue must be debrided13,27

Effective debridement removes necrotic tissue, eliminating the food source for bacteria13

Infection can be a significant barrier to healing13

Necrotic tissue is the food source, or grocery store, for bacteria

“Research has demonstrated that the presence of necrotic tissue in the wound bed is associated with wound infection, and its removal works on several levels to reduce bacterial burden.”13

Complete debridement with SANTYL Ointment can positively affect bioburden26

Ongoing, daily enzymatic debridement with SANTYL Ointment can be effectively used in conjunction with treatments that address infection, including certain silver dressings, wound cleansers, and antimicrobials.21

During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment than in patients treated with silver-based products (P=0.208).

Secondary endpoint: Incidence of target ulcer infection based on clinical signs and symptoms of infection during the six-week treatment period*

All 102 study subjects considered free of infection at enrollment

5

SANTYL Ointment group26

n=5 out of 51

(P=0.208)

11

Silver products group26

n=11 out of 51

*SANTYL Ointment is not indicated for the treatment or prevention of infection

Log in or register to download clinical study: Mean percent reduction in ulcer area with SANTYL Ointment vs silver-based products

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Related content

Clinical study: Compatibility of SANTYL Ointment with wound-care products, including silvers

Review case study

A patient with non–insulin-dependent diabetes mellitus (NIDDM) noticed a wound on his foot

Review case study
What's next?

Outcomes of sharp debridement with or without SANTYL Ointment
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.