Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Completed · Not applicable

Conditions studied: Chronic Wounds

In brief

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.

Key facts

Study ID

NCT01442103

Run by

Molnlycke Health Care AB

People needed

10

Starts

2011-09-01

Expected to finish

2012-05-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Joseph M. Still Research Foundation, Inc. — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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