Chronic Wounds
Conditions
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.
Interventions
DEVICENormlgel 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.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. | 4 weeks | Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Assessment | 4 weekks | Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit. |
| Pain Upon Application of Investigational Product. | 4 weeks | VAS pain scale will be used to measuring pain at each dressing change. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Silver Gel, Chronic Wounds Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Silver Gel, Chronic Wounds |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 58.7 years STANDARD_DEVIATION 18.7 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Common Dressing | Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. | 8 participants |
Secondary
Infection Assessment
Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.
Time frame: 4 weekks
Secondary
Pain Upon Application of Investigational Product.
VAS pain scale will be used to measuring pain at each dressing change.
Time frame: 4 weeks