title: The effect of different formulations of equivalent active ingredients on the performance of two topical wound treatment products.
abstract: Product selection for the management of pressure ulcers or perineal dermatitis is typically based on consideration of active 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 of two prescription products used for the treatment of pressure ulcers and perineal dermatitis. Both products contain equivalent active 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.
authors.affiliation: University of Virginia, Department of Urology and School of Nursing, Charlottesville, Va., USA. MG5K@hscmail.mcc.virginia.edu
authors.forename: Mikel
authors.initials: M
authors.lastname: Gray
authors.forename: David P
authors.initials: DP
authors.lastname: Jones
mesh_terms: D000336:Aerosols; D000368:Aged; D001004:Anus Diseases / Q000188:drug therapy*; D001453:Balsams / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D003872:Dermatitis / Q000188:drug therapy*; D006801:Humans; D009824:Ointments; D008517:Phytotherapy / Q000379:methods*; D003668:Pressure Ulcer / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000336:Aerosols; D001453:Balsams; D009824:Ointments; C025080:Peruvian balsam