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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Wounds

Intervention / Treatment
-----------------
* Device: Normlgel Ag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device, dressing<br>Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound. | Device: Normlgel Ag<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Assessment | Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit. | 4 weekks | 
| Pain Upon Application of Investigational Product. | VAS pain scale will be used to measuring pain at each dressing change. | 4 weeks |