Clinical Utility of a New Silver Gel for Use on Chronic Wounds
This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds|
- Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.
- Infection Assessment [ Time Frame: 4 weekks ] [ Designated as safety issue: Yes ]Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.
- Pain Upon Application of Investigational Product. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]VAS pain scale will be used to measuring pain at each dressing change.
|Study Start Date:||September 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Device, dressing
Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.
Device: Normlgel Ag
Normlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log.
Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442103
|United States, Georgia|
|Joseph M. Still Research Foundation, Inc.|
|Augusta, Georgia, United States, 30909|
|Principal Investigator:||Zaheed Hassan, MD||Josepth M. Still Research Foundation, Augusta, Georgia, US|