Clinical Utility of a New Silver Gel for Use on Chronic Wounds
|ClinicalTrials.gov Identifier: NCT01442103|
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : November 8, 2013
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment|
|Chronic Wounds||Device: Normlgel Ag|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds|
|Study Start Date :||September 2011|
|Primary Completion Date :||April 2012|
|Study Completion Date :||May 2012|
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.
- Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. [ Time Frame: 4 weeks ]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 ]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 ]VAS pain scale will be used to measuring pain at each dressing change.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|