Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects

This study has been completed.
  Summary: The purpose of this research study is to determine if omiganan 1% gel, which was the investigational medication in the study was effective and safe when compared to chlorhexidine 2% for killing bacteria that lives on the skin’s surfaces. Chlorhexidine is an FDA approved medication specifically designed to combat germs. Both medications used during the study were applied topically on the surface of the skin. This interventional, non-randomized study consisted of two parts with approximately 20 subjects participating in each part. Subjects considered eligible for Part 1 had omiganan 1% gel applied to six sites across the chest and/or abdomen and chlorhexidine 2% solution was applied to six matching sites on the contralateral side. All subjects considered eligible for Part 2 had omiganan 1% gel applied to six sites across the upper chest or abdomen. Additionally, participants in Part 2 had two peripheral catheters inserted, one in each arm. Both genders were eligible for the study as long as they were healthy. Inclusion criteria included participants between the ages of 18–70, with no evidence of dermatosis, dermatitis, inflammation, scarring, or acute injuries to the drug application sites on the chest or abdomen. Exclusion criteria included allergies or sensitivities to alcohol, adhesive tape, bandages, latex, chlorhexidine gluconate, or any of the ingredients of omiganan 1% gel; prior treatment with any systemic antibiotic, or any other product known to affect the normal microbial flora on the skin within 7 days of the screening examination and a current or recent history of illicit drug or alcohol abuse. Women of childbearing potential who had a positive or equivocal result on a urine and/or blood pregnancy test before study enrollment were not included. Primary research outcome measures were the change in mean number of skin bacterial counts from baseline to 72 hours (time frame: prior to first application [0 hours] to 72 hours post application); change in mean number of skin bacterial counts from baseline to 7 days (time frame: prior to first application [0 hours] to 7 days post application); and the number of subjects with significantly colonized catheters, defined as ≥ 15 colony forming units ([CFUs] time frame: each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days).
  Location: BioSciences Lab, Bozeman, Montana
  Sponsor: Cadence Pharmaceuticals
  Principle investigator: Catherine J. Hardalo, MD Cadence Pharmaceuticals, Inc, San Diego, California
  Identifier: NCT00608959

The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

This study has been completed.
  Summary: The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate for quite some time; however, limited data in humans and further prospective randomized studies are warranted. The aim of this study was to further study the effects of the preoperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective, randomized double-blind study on bone healing, pain, and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardized surgical technique including an ostomy of metatarsal I and excision of exostosis. The participating patients were randomized into two groups; each group consisted of 50 patients each. Group 1 received etoricoxib 90 mg once daily x 5 and Group 2 received tramadol 100 mg twice daily x 5.