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COLLAGENASE SANTYL ointment 250 units/g [SMITH & NEPHEW, INC] | COLLAGENASE SANTYL [SMITH & NEPHEW, INC] | BioPortfolio

12:44 EST 27th January 2019 | BioPortfolio

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Collagenase Santyl Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue.

Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly effective in the removal of detritus.   Collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas. Collagen in healthy tissue or in newly formed granulation tissue is not attacked. There is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier.

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

Collagenase Santyl Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

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. When it is suspected such materials have been used, the site should be carefully cleansed by repeated washings with normal saline before Collagenase Santyl Ointment is applied. Soaks containing metal ions or acidic solutions should be avoided because of the metal ion and low pH. Cleansing materials such as Dakin’s solution and normal saline are compatible with Collagenase Santyl Ointment.

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 Collagenase Santyl Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatric patients have not been established.

No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. However, one case of systemic manifestations of hypersensitivity to collagenase in a patient treated for more than one year with a combination of collagenase and cortisone has been reported.

No systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. If deemed necessary the enzyme may be inactivated by washing the area with povidone iodine.

Collagenase Santyl Ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). When clinically indicated, crosshatching thick eschar with a #10 blade allows Collagenase Santyl Ointment more surface contact with necrotic debris. It is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily. Use Collagenase Santyl Ointment in the following manner:

1 - Prior to application the wound should be cleansed of debris and digested material by gently rubbing with a gauze pad saturated with normal saline solution, or with the desired cleansing agent compatible with Collagenase Santyl Ointment (See PRECAUTIONS ), followed by a normal saline solution rinse.

2 - Whenever infection is present, it is desirable to use an appropriate topical antibiotic powder. The antibiotic should be applied to the wound prior to the application of Collagenase Santyl Ointment. Should the infection not respond, therapy with Collagenase Santyl Ointment should be discontinued until remission of the infection.

3 - Collagenase Santyl Ointment may be applied directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured.

4 - Use of Collagenase Santyl Ointment should be terminated when debridement of necrotic tissue is complete and granulation tissue is well established.

Collagenase Santyl Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP.

Do not store above 25°C (77°F). Sterility guaranteed until tube is opened.

Collagenase Santyl Ointment is available in the following sizes:

30 g tube NDC 50484-010-30

90 g tube NDC 50484-010-90

REFERENCES

1 – Mandl, I., Adv Enzymol. 23:163, 1961.

2 – Boxer, A.M., Gottesman, N., Bernstein, H., & Mandl, I., Geriatrics. 24:75, 1969.

3 – Mazurek, I., Med. Welt. 22:150, 1971.

4 – Zimmermann, WE., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p. 185.

5 – Vetra, H., & Whittaker, D., Geriatrics. 30:53, 1975.

6 – Rao, D.B., Sane, P.G., & Georgiev, E.L., J. Am. Geriatrics Soc. 23:22, 1975.

7 – Vrabec, R., Moserova, J., Konickova, Z., Behounkova, E., & Blaha, J., J. Hyg. Epidemiol. Microbiol. Immunol. 18:496, 1974.

8 – Lippmann, H.I., Arch. Phys. Med. Rehabil. 54:588, 1973.

9 – German, F. M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165.

10 – Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 177.

11 – Lee, L.K., & Ambrus, J.L., Geriatrics. 30:91, 1975.

12 – Locke, R.K., & Heifitz, N.M., J. Am. Pod. Assoc. 65:242, 1975.

13 – Varma, A.O., Bugatch, E., & German, F.M., Surg. Gynecol. Obstet. 136:281, 1973.

14 – Barrett, D., Jr., & Klibanski, A., Am. J. Nurs. 73:849, 1973.

15 – Bardfeld, L.A., J. Pod. Ed. 1:41, 1970.

16 – Blum, G., Schweiz, Rundschau Med Praxis. 62:820, 1973. Abstr. in Dermatology Digest, Feb. 1974, p. 36.

17 – Zaruba, F., Lettl, A., Brozkova, L., Skrdlantova, H., & Krs, V., J. Hyg. Epidemiol. Microbiol. Immunol. 18:499, 1974.

18 – Altman, M.I., Goldstein, L., & Horwitz, S., J. Am. Pod. Assoc. 68:11, 1978.

19 – Rehn, V.J., Med. Klin. 58:799, 1963.

20 – Krauss, H., Koslowski, L., & Zimmermann, W. E., Langenbecks Arch. Klin. Chir. 303:23, 1963.

21 – Gruenagel, H.H., Med. Klin. 58:442, 1963.

Manufactured by: SMITH & NEPHEW, INCFort Worth, Texas 76109

US Gov’t License #2004

Marketed by: Smith & Nephew

1-800-441-8227

Smith & Nephew, Inc., Fort Worth, Texas 76109

© 2016 Smith & Nephew, Inc.

SANTYL is a registered trademark of Smith & Nephew, Inc.

140749-0316

Manufacturer

SMITH & NEPHEW, INC

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Effect of Collagenase on Healing and Scarring

A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment ver...

Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting scar.

MEDIHONEY® Gel Versus Collagenase for Wound Debridement

The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.

Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers

This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, par...

Use of Santyl Within an Accountable Care Organization

This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care...

PubMed Articles [54 Associated PubMed Articles listed on BioPortfolio]

Effect of optimized collagenase digestion on isolated and cultured nucleus pulposus cells in degenerated intervertebral discs.

This study aims to explore the optimized digestive method of collagenase to nucleus pulposus (NP) cells by observing the digestive effects of type I and II collagenase in different concentrations to N...

U32 collagenase from Pseudoalteromonas agarivorans NW4327: Activity, structure, substrate interactions and molecular dynamics simulations.

A protease of the primary pathogen (Pseudoalteromonas agarivorans NW4327) of the disease affecting the Great Barrier Reef sponge Rhopaloeides odorabile was purified. Zymography demonstrated calcium-de...

Factors predicting the 1-year outcome of collagenase treatment for Dupuytren's disease.

Several studies have investigated the clinical outcome after collagenase treatment for Dupuytren's disease in terms of range of motion of the affected finger. However, good objective clinical outcome ...

The C-terminal segment of collagenase in binds collagen to enhance collagenolysis.

The collagenase secreted by strain 1706B is a 74 kDa protein that consists of two parts: the catalytic module and a C-terminal segment that includes the bacterial pre-peptidase C-terminal domain. He...

Collagenase injections for Dupuytren's contracture: prospective cohort study in a public health setting.

Dupuytren's disease causes a flexion contracture of the hand that limits hand function and reduces quality of life. Traditional management is surgical excision which is associated with potentially ser...

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