New Study Reveals Collagenase SANTYL® Ointment More Effective Than Hydrogel Dressing for Pressure Ulcer Debridement

FORT WORTH, Texas, Sept. 30 /PRNewswire/ -- Healthpoint today announced that the results of a new study conducted by Catherine T. Milne APRN, MSN, CWOCN, BC-ANP, will be presented on Thursday, September 30, 2010 at 7:15pm (Eastern) at the Healthpoint booth (#110) during the 25th Annual Clinical Symposium on Advances in Skin & Wound Care: The Conference for Prevention and Healing. The conference is being held from September 30 to October 3, 2010, at the Gaylord Palms Resort & Convention Center in Orlando, Florida. Ms. Milne will also deliver encore presentations of her study results at 11:15am (Eastern) on Friday, October 1st, and 12:45pm (Eastern) on Saturday, October 2nd; all presentations will be held in The Wound Institute® Theatre located inside of the Healthpoint booth.

The study was designed to evaluate the comparative efficacy of Collagenase SANTYL® Ointment to a hydrogel dressing as measured by time to complete wound debridement (dead tissue removal) of pressure ulcers. Twenty-seven nursing home residents were enrolled and randomized to receive either Collagenase SANTYL® Ointment (N=13) -- an enzymatic debriding agent -- or a hydrogel dressing (N=14). Investigators blinded to randomization evaluated weekly wound photographs using a digital planimetry software package for debridement. The Collagenase-treated group achieved statistical significance in complete debridement by day 42 as compared to the hydrogel-treated group (p<.003); eleven of the 13 Collagenase-treated patients (85%) vs. four of the 14 hydrogel-treated patients (29%) experienced complete debridement by day 42.

"To date, studies comparing Collagenase to hydrogel have not been reported in the literature," noted Catherine T. Milne, APRN, MSN, CWOCN of the Bristol Hospital Wound, Ostomy, Lymphedema Center in Bristol, Connecticut and the study's principal investigator. "The findings of the present study are particularly relevant for clinicians in the long-term care setting where pressure ulcers continue to be a challenging issue requiring effective and convenient treatment solutions."

In difficult-to-heal and chronic wounds (such as diabetic, venous, and pressure ulcers) there is a continuous deposition of fibrotic and necrotic tissue that must be removed to maintain the readiness of the wound for healing. The process of removing these barriers to healing is called debridement.

Enzymatic debridement refers to the use of certain enzymes (types of proteins) to liquefy necrotic (dead) tissue, thus allowing bioburden to be more easily removed from the wound. More specifically, the collagenase enzyme liquefies the collagen fibers within necrotic tissue, the cellular and fibrotic debris (i.e., "bioburden") loosen their connections from each other and the wound bed, so they more easily wash away during routine cleansing at each dressing change.

Effective debridement to remove necrotic tissue, bacterial burden and the cellular debris of dead and abnormal cells is widely recognized as a critical first step in preparing a wound to heal. This consensus is supported by clinical studies that have shown that, in the presence of necrotic tissue, healing rates improve with increasing efficiency and frequency of debridement. There is also wide agreement that debridement should no longer be considered a one-time event; rather, effective ongoing or maintenance debridement until granulation tissue is well established should be provided to keep the wound microenvironment free of necrotic, bacterial and cellular barriers that can interfere with the wound's ability to progress toward healing.

"We are pleased to have provided support for this study as part of Healthpoint's ongoing commitment to research initiatives that contribute to the knowledge base of the clinical community," said Robert Bancroft, Executive Vice President, Strategic and Commercial Development of Healthpoint.  

The study was supported by an unrestricted research grant from Healthpoint and the results will be published in the November issue of Wounds.

About Collagenase SANTYL® Ointment

Collagenase SANTYL® Ointment is a selective enzymatic debriding agent that contains 250 collagenase units per gram of white petrolatum USP. It is indicated for debriding chronic dermal ulcers and severely burned areas*. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum and possesses the ability to liquefy collagen in necrotic tissue. Collagenase SANTYL® Ointment is the only FDA-approved brand of enzymatic debrider available in the United States.

*Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. See complete prescribing information online at: http://www.santyl.com/prescribing.

About HEALTHPOINT, Ltd.

Since 1992, HEALTHPOINT has been dedicated to innovative technologies for the prevention and treatment of acute, chronic and burn-related wounds. The company is presently focused on the research and development of novel biologics and pharmaceuticals intended to improve clinical and quality of life outcomes. Currently marketed products include: Collagenase SANTYL® Ointment, OASIS® Wound Matrix and HYDROFERA BLUE® Bacteriostatic Wound Dressings. HEALTHPOINT is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from THE WOUND INSTITUTE®. To learn more about this comprehensive and award winning educational resource, please visit TheWoundInstitute.com®. HEALTHPOINT is a DFB Pharmaceuticals, Inc. affiliate company, and is based in Fort Worth, Texas. For more information, visit the HEALTHPOINT website at www.healthpoint.com.

Healthpoint and design, SANTYL, THE WOUND INSTITUTE and THEWOUNDINSTITUTE.COM are registered trademarks of Healthpoint, Ltd.

OASIS is a registered trademark of Cook Biotech, Inc.

HYDROFERA BLUE is a registered trademark of Hydrofera, LLC.

SOURCE HEALTHPOINT, Ltd.