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

NCT01442103 | Completed Results

• 1 other identifier: Ngel Ag 01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.

  Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.

  4 weeks

Secondary Outcomes (2)

• Infection Assessment

  4 weekks

• Pain Upon Application of Investigational Product.

  4 weeks

Study Arms (1)

Device, dressing

EXPERIMENTAL

Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.

Device: Normlgel Ag

Interventions

Normlgel Ag DEVICE

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.

Device, dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, 30909, United States

Location

Limitations and Caveats

Small study population, 2 patients lost to follow-up.

Results Point of Contact

• Title: Joan wilson
• Organization: Molnlycke Health Care

joan.wilson@molnlycke.com

+1 706-650-1012

Study Officials

• Zaheed Hassan, MD

  Josepth M. Still Research Foundation, Augusta, Georgia, US

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 28, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 14, 2016
• Results First Posted: November 8, 2013

Record last verified: 2012-11

Locations

US (1)