Clinical trial NCT01442103: Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Official title: Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wounds
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Both genders with an age \>18 years
3. 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
4. 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
5. Study site to include only ONE wound to be treated

Exclusion Criteria:

1. 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.
2. Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
3. Wound \> 1 year old
4. Wound \> 10 cm x 10 cm (l x w)
5. Wound \> 6 cm deep
6. Use of chemical/enzymatic and biological debridement within 7 days of investigation start
7. Necrotizing wounds
8. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
9. Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
10. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
11. Known allergy/hypersensitivity to any of the components of the investigation products.
12. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
13. Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation

Primary outcomes:
measure: Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.
timeFrame: 4 weeks
Secondary outcomes:
measure: Infection Assessment
timeFrame: 4 weekks
measure: Pain Upon Application of Investigational Product.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation, Inc.
state: Georgia
Study officials:
affiliation: Josepth M. Still Research Foundation, Augusta, Georgia, US
name: Zaheed Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: