Efficacy of Wound Care Dressings (With Reported Results)

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. Primary study variables included X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modeling of the ostomy at 12 weeks following surgery; the number of patients requiring rescue medication; and patient assessment using “brief pain inventory” 24 hours and 2 weeks after surgery. Ekman et al studied in a prospective randomized double-blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. The researchers found significant effects on reduction of pain and need for opioid analgesics postoperatively but saw no negative effects pertaining to the numbers of “non-unions” at a 1-year follow up. In a similar prospective, randomized double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament.   Location: Foot & Ankle Surgical Center, Stockholm, Sweden   Sponsor: Karolinska Institutet   Principle investigator: Jan Jakobsson, MD, PhD Foot & Ankle Surgical Center   Identifier: NCT00733421

Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodessication

This study has been completed.   Summary: The overall purpose of this pilot clinical study was to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist Procellera™ antimicrobial wound dressing when compared to standard dressing, Mepilex® Border Lite, following curettage and electrodessication of skin lesions. Persons ages 18–80 were eligible for the study and while both genders were eligible, female participants had to either not be of childbearing potential, or if they were of childbearing potential, they needed a negative urine pregnancy test. Additionally, other inclusion criteria were wound size greater than 1 cm x 1 cm; wounds had to be ≥ 5cm away from all other wounds; and participants had to be able to read and understand informed consent and sign the informed consent. The following entails factors of exclusion criteria: concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study; participants with sensitivity or adverse reactions to silver or zinc; female participants pregnant or nursing an infant child; immunosuppression; diabetes; collagen vascular disease; and chronic steroid use. Enrollment began in March 2008 and concluded in October 2008. For Procellera antimicrobial dressing, which served as the experimental arm, dressings changes took place every 3 days, more frequently if needed. This dressing is indicated specifically for partial full-thickness wounds. Mepilex Border Lite, a self-adherent foam dressing, was also utilized and dressing changes occurred every 2–3 days and more frequently if needed. The Band-Aid® Adhesive Bandage: Active Comparator served as the adhesive bandage. The primary outcome measure for this study was the number of patients who experienced 50% or greater wound healing. Participants were assessed to see whether or not the wound area was reduced by at least 50% and the number of such participants was reported. Secondary outcome measures consisted of the number of patients reporting pain (time frame was 3 weeks); and participants recorded their subjective pain level on a 0–10 numeric pain chart 3x/day (0 = no pain, 10 = worst pain imaginable), until patients had no pain for 3 consecutive days. At each weekly follow-up visit, wound erythema was evaluated by the clinician on scale of 0–4 with “0” being “no erythema,” “1” being “very slight erythema,” “2” being “well defined erythema,” “3” being “moderate to severe erythema,” and “4” being “severe erythema to slight eschar formation.”   Location: Sheftel Associates Dermatology Tucson, Arizona   Sponsor: Vomaris Innovations   Principle investigator: Scott N. Sheftel, MD Sheftel Associates Dermatology, Tucson, Arizona   Identifier: NCT00816101 The information contained in this update was summarized from www.clinicaltrials.gov. Copyright © US National Library of Medicine.