Partial-thickness Burn
Conditions
Keywords
infected or risk of infection
Brief summary
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection. Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
Detailed description
The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study. The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The product has a classification III, as it contains the active ingredient silver. The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU. The total study duration for the subject will be approximately two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (V0/V1, V2 and V3). V3 will also terminate the 2-week study period. The primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) The clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.
Interventions
DEVICEGelling fiber wound dressing with silver
intervention involving a wound dressing with silver
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-comparative, one-armed, open-labelled, multi-centre study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Has signed informed consent 2. Is between 18 -65 years (both included) 3. Is capable of following study procedure (assessed by investigator). 4. Has a partial thickness burn wound 5. Has a burn wound that is infected or at risk of infection (assessed by investigator) 6. The size of burn (including both study wound and non-study injuries) has a Total Body Surface Area (TBSA) less than 10% (assessed by investigator). 7. The wound should fit under a 20x30 cm dressing (600 cm2) or smaller 8. The shape and location of the wound should be suitable for photo capture (assessed by the investigator). 9. Has a wound that has medium to high level of exudate (assessed by the investigator) 10. Is suitable to use the test product for wound treatment (assessed by the investigator).
Exclusion criteria
1. Is pregnant/breastfeeding 2. Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) 3. Known history of skin sensitivity to any components of the test dressings 4. \>72 hours from time of injury 5. Intake of antibiotics within one week before the start of the enrolment 6. Use of chemical debridement 7. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wounds Healed Within 14 Days | 2 weeks | The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Main Arm Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment.
Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week.
The test dressing is a gelling fiber wound dressing with silver applied to the study wounds. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Main Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 49 Participants | — |
| Age, Continuous | 38.9 years | — |
| Area of subjects' study wound | 52.0 cm^2 | — |
| Number of Participants with Signs of Infection in the Wound | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 51 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 25 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 10 / 52 |
| serious Total, serious adverse events | 1 / 52 |
Outcome results
Primary
Percentage of Wounds Healed Within 14 Days
The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater.
Time frame: 2 weeks
Population: Primary analysis was based on the full analysis set for subjects with non-missing data (completers).~Post hoc sensitivity analysis and supplemental analysis were based on the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Arm | Percentage of Wounds Healed Within 14 Days | Primary analysis (subjects with non-missing data, completers) | 83.7 percentage of wounds healed |
| Main Arm | Percentage of Wounds Healed Within 14 Days | Post hoc sensitivity analysis (missing data imputed as not healed or using multiple imputation) | 74.8 percentage of wounds healed |
| Main Arm | Percentage of Wounds Healed Within 14 Days | Supplemental analysis (missing data imputed as not healed) | 70.6 percentage of wounds healed |