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
  Purpose

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.


Condition Intervention
Chronic Wounds
Device: Normlgel Ag

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device, dressing
Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442103

Locations
United States, Georgia
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Zaheed Hassan, MD Josepth M. Still Research Foundation, Augusta, Georgia, US
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01442103     History of Changes
Other Study ID Numbers: Ngel Ag 01
Study First Received: September 13, 2011
Results First Received: July 1, 2013
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014