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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01442103
First received: September 13, 2011
Last updated: October 16, 2013
Last verified: November 2012

September 13, 2011
October 16, 2013
September 2011
April 2012   (final data collection date for primary outcome measure)
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.
Same as current
Complete list of historical versions of study NCT01442103 on ClinicalTrials.gov Archive Site
  • Infection Assessment [ Time Frame: 4 weekks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    VAS pain scale will be used to measuring pain at each dressing change.
Same as current
Not Provided
Not Provided
 
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Wounds
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.
Experimental: Device, dressing
Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.
Intervention: Device: Normlgel Ag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01442103
Ngel Ag 01
No
Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Zaheed Hassan, MD Josepth M. Still Research Foundation, Augusta, Georgia, US
Molnlycke Health Care AB
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP