Wounds and Injuries
Conditions
Brief summary
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination
Detailed description
A prospective randomized clinical investigation will be conducted at two sites in Sweden. Male or female, 18 years or older with following wound types: * traumatic, surgical or dehisced wounds, * venous leg ulcer or pressure ulcer will be included into the clinical investigation. 32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.
Interventions
DEVICESilicon adhesive dressing
Sterile soft silicon adhesive dressing
DEVICEAcrylic adhesive dressing
Sterile acrylic adhesive dressing
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy 2. In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference. 3. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound 4. Male or female, 18 years of age and above 5. Signed Informed Consent
Exclusion criteria
1. Dressing sizes does not fit the target wound 2. Unexplored blind tunnels or non-enteric fistula 3. Untreated osteomyelitis 4. Malignant wounds 5. Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. 6. Wounds with necrotic tissue or eschar (if not adequately debrided) 7. Significantly bleeding wounds, as judged by the investigator 8. Subject not suitable for the investigation according to the investigator's judgment 9. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator 10. Known allergy/hypersensitivity to any of the components included into the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Peri-Wound Skin | Visit 4 last visit (day 12) | The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Scale (0-100mm) | 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12) | Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avance® Film With Safetac® Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Avance® Film With Safetac® | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Baseline Pain | 1.5 score on a scale STANDARD_DEVIATION 1.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 2 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Changes on Peri-Wound Skin
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
Time frame: Visit 4 last visit (day 12)
Population: No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). Due to missing values for the one subject that completed follow up, the primary outcome is presented at 12 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avance® Film With Safetac® | Changes on Peri-Wound Skin | 3 score on a scale |
Secondary
VAS Scale (0-100mm)
Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.
Time frame: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)
Population: No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). All data is presented for the one subject throughout their follow up of 4 visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain DURING removal of the foam filler | 5 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain AFTER removal of the foam filler | 5 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain BEFORE removal of the covering film | 4 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain DURING removal of the covering film | 17 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain AFTER removal of the covering film | 17 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain BEFORE removal of the foam filler | 4 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain DURING removal of the foam filler | 6 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 4: Pain AFTER removal of the foam filler | 9 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 1: Pain before application of NPWT | 3 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain BEFORE removal of the covering film | 2 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain DURING removal of the covering film | 27 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain AFTER removal of the covering film | 2 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain BEFORE removal of the foam filler | 5 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain DURING removal of the foam filler | 2 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 2: Pain AFTER removal of the foam filler | 2 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain BEFORE removal of the covering film | 19 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain DURING removal of the covering film | 12 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain AFTER removal of the covering film | 10 score on a scale (0-100) |
| Avance® Film With Safetac® | VAS Scale (0-100mm) | Visit 3: Pain BEFORE removal of the foam filler | 2 score on a scale (0-100) |