The Effect of Different Formulations of Equivalent Active Ingredients on the Performance of TwoTopical Wound Treatment Products

Improved Healthcare Outcomes in Partial Thickness Wounds Case Studies Demonstrating Xenaderm™ Ointment as a Cost-Effective Topical Therapy for Partial Thickness Wounds

Experimental Methods to Demonstrate the Efficacy and Safety of Xenaderm™ Ointment: A Novel Formulation for Treatment of Injured Skin due to Pressure Ulcers

Using a Castor Oil-Balsam of Peru-Trypsin Ointment to Assist in Healing Skin Graft Donor Sites

The Effect of Different Formulations of Equivalent Active Ingredients on the Performance of TwoTopical Wound Treatment Products

Journal: Ostomy Wound Management (2004)

Authors: Mikel Gray, PhD, CUNP, CCN, FAAN; and David P. Jones, BSc

Abstract: Product selection for the management of pressure ulcers orperineal dermatitis is typically based on consideration ofactive ingredients, but a growing body of evidence suggests that delivery vehicles also may influence product safety and efficacy. A 10-day, randomized, controlled experimental study was conducted to compare the safety and efficacy oftwo prescription products used for the treatment of pressure ulcers and perineal dermatitis. Both products contain equivalentactive ingredients (balsam of Peru, castor oil, and trypsin), but one product delivers these ingredients in an ointment base while the other uses an aerosol spray. Sixty healthy volunteers (> 65 years of age) underwent intentional creation of two equivalent skin wounds (approximately 6 mm in diameter) using an Erbium-YAG laser. Volunteers served as their own control. Wounds were randomized to treatment with one of the balsam of Peru products or saline. Wounds were evaluated every other day. Significant differences between treatments were observed for most outcome variables (edema, scabbing, erythema, epithelialization). Wounds managed with the ointment-based product had lower edema, scabbing, and erythema scores and higher epithelialization scores than the spray or saline managed wounds. The results of this study confirm that formulation of the vehicle base can have a significant effect on product safety and effectiveness.

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Improved Healthcare Outcomes in Partial Thickness Wounds Case Studies Demonstrating Xenaderm™ Ointment as a Cost-Effective Topical Therapy for Partial Thickness Wounds

Journal: Ostomy/Wound Management (2004)

Authors: Linda Bohacek, RN, CWS, WOCN; Kathleen Farley, MS, RN

Abstract: The demands of managed care have presented clinical challenges within the specialized field of wound care. Limited reimbursement and treatment timelines delineated by managed care have demanded clinicianssearch for alternative wound-healing therapies. The results of 5 case studies are reported in this article, demonstrating enhanced reepithelialization of partial thickness wounds with the application of Xenaderm� Ointment. In addition, a review is made of the product's safety and efficacy, pharmacoeconomics, and improved healthcare outcomes. Xenaderm Ointment is demonstrated to be an effective topical therapy for partial thickness wounds through the following case studies,and data reviewed from prior clinical trials.

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Experimental Methods to Demonstrate the Efficacy and Safety of Xenaderm™ Ointment: A Novel Formulation for Treatment of Injured Skin due to Pressure Ulcers

Journal: Wounds Supplement(2003)

Authors: Rainer Maas-Irslinger , MD ; Christopher N. Hensby, PhD; Kathleen L. Farley, MS, RN

Abstract: Several controlled studies were performed in different subjects to evaluate the effects of a patented ointment base containing trypsin, castor oil, and balsam Peru (Xenaderm�) on local blood flow,intact skin, and injured skin. Ten healthy subjects between the ages of 30 and 55 years were entered intoa trial to evaluate the effect of topically applied Xenaderm on local blood flow at the site of application.Xenaderm (25µL) was applied to the intact volar skin of one forearm and compared with untreated skin. At three hours post-treatment, differences between the treated and untreated arms for blood flow (flux), blood flow change from baseline, and percent change from baseline were all statistically significant (p < 0.01). At this time point, the mean of individual subject changes in blood flow increased in the treated area by 45.4 percent compared with no change in the untreated area. A separate experimental wound healing study in 19 subjects showed several measures of wound healing (erythema, scabbing, and reepithelialization after treatment of a laser-induced skin wound) were all in favor of Xenaderm compared with control. In a transepidermal water loss study involving 16 subjects, exposure to Xenaderm did not interfere with healing of experimentally traumatized skin and may, in fact, have a positive effect as a protective barrier. Lastly, Xenaderm did not show any potential for contact sensitization in a repeated insult patch test (RIPT) conducted on 212 subjects. Overall, these studies support that Xenaderm increases local blood flow, may be an effective early intervention in the treatment of pressure ulcers, and is safe on compromised and intact skin.

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Using a Castor Oil-Balsam of Peru-Trypsin Ointment to Assist in Healing Skin Graft Donor Sites

Journal: Ostomy/Wound Management (2003)

Authors: Stanley N. Carson, MD, FACS; Christopher Wiggins, MBA; Karen Overall, PT, CWS; and Jackie Hebert, PTA, CWS

Abstract: Skin graft donor sites are partial-thickness wounds that are commonly managed with gauze-type dressings. As such, they often cause more pain and difficulty in healing than the graft-recipient site. A retrospective study was conducted to ascertain the effects of using a castor oil-balsam of Peru-trypsin containing ointment on skin graft donor sites in 36 consecutive patients (16 female, 20 male). All donor sites were epithelialized after 11 days (range 6 to 11 days, mean 8 days) and no wound complications were observed. Given these healing results and product ease of use, this particular formulation has become the facilities' current treatment of choice and further study is indicated and warranted.

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