Clinical Utility of a New Silver Gel for Use on Chronic Wounds
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|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||Phase|
|Chronic Wounds||Device: Normlgel Ag||Not Applicable|
|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|
|Actual Primary Completion Date :||April 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|