Status:
COMPLETED
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Chronic Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 esc...
Eligibility Criteria
Inclusion
- Signed informed consent
- Both genders with an age \>18 years
- Subjects with chronic wounds \< 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
- Erythema
- Edema
- Warmth
- Increased drainage
- Foul odor
- Subject's wounds may also present with:
- presence of eschar or slough that needs to be treated prior to normal standard of care OR
- A need for topical care after debridement
- Study site to include only ONE wound to be treated
Exclusion
- Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
- Wound \> 1 year old
- Wound \> 10 cm x 10 cm (l x w)
- Wound \> 6 cm deep
- Use of chemical/enzymatic and biological debridement within 7 days of investigation start
- Necrotizing wounds
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
- Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
- Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
- Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01442103
Start Date
September 1 2011
End Date
May 1 2012
Last Update
April 14 2016
Active Locations (1)
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1
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States, 30909