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

Chronic Wounds Clinical Trial

Official title:

Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442103
• Other study ID #: Ngel Ag 01
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: October 16, 2013
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Wounds

Intervention

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.

Locations

Country	Name	City	State
United States	Joseph M. Still Research Foundation, Inc.	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Infection Assessment	Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.	4 weekks	Yes
Secondary	Pain Upon Application of Investigational Product.	VAS pain scale will be used to measuring pain at each dressing change.	4 weeks	Yes