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

NCT ID: NCT01442103

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-05-31

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.

Conditions

Chronic Wounds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device, dressing

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

Group Type: EXPERIMENTAL

Normlgel Ag

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zaheed Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, United States

Countries

United States

Other Identifiers

Ngel Ag 01

Identifier Type: -

Identifier Source: org_study_id