N/A
Completed N=10
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Source: ClinicalTrials.gov NCT01442103 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. — 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. |
8 | — |
| SECONDARY Infection Assessment |
— | — |
| SECONDARY Pain Upon Application of Investigational Product. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Both genders with an age >18 years
- Subjects with chronic wounds 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
Data sourced from ClinicalTrials.gov (NCT01442103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.