Rule 24.165.518 - DEBRIDING AGENTS PROTOCOLS(1) Within the class of debriding agents, only the following subclasses are approved for use by a clinician on a patient: (a) papain-based ointments; (b) papain with urea additives; (e) endogenous platelet-derived growth factors; and (2) Clinicians may use papain-based ointments as directed by a licensed medical practitioner with prescriptive authority. (a) Papain-based ointments act via a proteolytic enzyme that digests nonviable proteins, but which is harmless to viable tissues.(b) Papain-based ointments are indicated for debriding necrotic tissue and liquefying slough in acute and chronic lesions, trauma wounds, or infected lesions.(c) Papain-based ointments are contraindicated for patients with known sensitivities to papain or any other ingredient of the medication. (3) Clinicians may use papain with urea additive agents as directed by a licensed medical practitioner with prescriptive authority.(a) Papain with urea additive acts as a denaturant to proteins, helps expose papain's activators by a solvent action, rendering them more susceptible to enzymatic digestion.(b) Papain with urea additive indications are for treating acute and chronic lesions including but not limited to: (ii) diabetic and decubitus ulcers; (iv) postoperative wounds; (v) pilonidal cyst wounds; (vii) traumatic or infected wounds. (c) Papain with urea additive has no known contraindications.(4) Clinicians may use anti-inflammatory agents as directed by a licensed medical practitioner with prescriptive authority. (a) Anti-inflammatory agents act to decrease histamine reactions to peri-wound areas, decreasing inflammation, and encouraging remodeling.(b) Anti-inflammatory agents are indicated for relieving inflammation and pruritis caused by dermatosis.(c) Anti-inflammatory agents are contraindicated for patients with known sensitivity to any components of the preparation.(5) Clinicians may use collagenase agents as directed by a licensed medical practitioner with prescriptive authority. (a) Collagenase agents act by digesting collagens in necrotic tissues, without destroying healthy granulation, and by encouraging epithelialization.(b) Collagenase agents are indicated debriding chronic dermal ulcers and severely burned areas(c) Collagenase agents are contraindicated for patients with local or systemic hypersensitivity to collangenases. (6) Clinicians may use endogenous platelet derived growth factor agents as directed by a licensed medical practitioner with prescriptive authority. (a) Endogenous platelet derived growth factor agents act by promoting chemotactic recruitment and the proliferative stage of healing. They enhance formation of granulation tissue. (b) Endogenous platelet derived growth factors are indicated for diabetic neuropathic ulcers that extend into subcutaneous tissue with an adequate blood supply.(c) Endogenous platelet-derived growth factor agents are contraindicated for patients with known hypersensitivity, including but not limited to parabens. Endogenous platelet-derived growth factor agents are not for use with wounds that close by primary intention because they are a nonsterile, low bioburden, preserved product.(7) Clinicians may use fibrinolytics as directed by a licensed medical practitioner with prescriptive authority. (a) Fibrinolytics act by contributing to collagen synthesis, where over-production of collagen can cause poor remodeling of the wound. (b) Fibrinolytics are indicated in patients who exhibit painful, indurated wounds. Fibrinolytics are also indicated in slow healing venous wounds. Fibrinolytics are only used adjunctively in therapy.(c) Fibrinolytics are contraindicated in patients who are allergic or exhibit a sensitivity to steroids. Fibrinolytics are also contraindicated when used alone in the treatment of wounds.Mont. Admin. r. 24.165.518
NEW, 2005 MAR p. 447, Eff. 4/1/05; AMD, 2019 MAR p. 1743, Eff.10/5/2019AUTH: 37-24-201, 37-24-202, MCA IMP: 37-24-108, 37-24-109, MCA