Pressure Ulcers
Conditions
Brief summary
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
Interventions
DEVICEFast Gelling Dressing (Exufiber)
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. Both gender ≥18 years old. 2. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP) 3. Exuding pressure ulcer 4. Signed Informed Consent.
Exclusion criteria
1. Known allergy/hypersensitivity to the dressing. 2. Infected wounds, (2 signs of infection/local inflammation and a positive swab) 3. Stage 1 PU 4. Dry wounds 5. Subjects who will have problems following the protocol 6. Subjects included in other ongoing clinical investigation at present or during the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) | 6 weeks | the subjects will be measured by the following variables; maceration, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance | 6 weeks | Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm |
Countries
Belgium, Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fast Gelling Dressing Fast Gelling Dressing (Exufiber) | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Fast Gelling Dressing |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 19.9 |
| Region of Enrollment Belgium | 14 participants |
| Region of Enrollment Finland | 7 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
the subjects will be measured by the following variables; maceration,
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fast Gelling Dressing | Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) | 2 participants |
Secondary
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fast Gelling Dressing | Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance | 0 units on a scale |