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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device, dressing | Experimental | Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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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:
Subject's wounds may also present with:
Study site to include only ONE wound to be treated
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaheed Hassan, MD | Josepth M. Still Research Foundation, Augusta, Georgia, US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Research Foundation, Inc. | Augusta | Georgia | 30909 | United States |
PreAssignment details:
There was not wash-out or run-in phase included in the study. Subjects were expected to have at least 2 signs of local irritation or inflammation but no active or systemic infection at the time of consent.
The recruitment period was from 15 September 2011 - 01 May 2012. The study was conducted at the Advanced Burn and Wound Clinic at the Joseph M. Still Burn Center in Augusta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver Gel, Chronic Wounds | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver Gel, Chronic Wounds | Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit. | Posted | Number | participants | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Common Dressing | Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund |
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Small study population, 2 patients lost to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan wilson | Molnlycke Health Care | +1 706-650-1012 | joan.wilson@molnlycke.com |
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| 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Infection Assessment | Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit. | Not Posted | 4 weekks |
| Secondary | Pain Upon Application of Investigational Product. | VAS pain scale will be used to measuring pain at each dressing change. | Not Posted | 4 weeks |
| 0 |
| 10 |
| 0 |
| 10 |
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