Diabetic Foot Ulcer, Leg Ulcer, Pressure Ulcer
Conditions
Brief summary
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.
Interventions
DEVICELeia
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Low to highly exuding chronic wound(wound history \> 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer * Male of female, 18 years and above * Signed Informed Consent Form
Exclusion criteria
* Pregnancy or lactation * Wound size not suitable for the wound dressing size * Known allergy/hypersensitivity to any of the components in the dressing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absorption of Wound Exudates. | 2-3 weeks | Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Leia and Hydroactive Surgical Dressing In the case of this study, participants served as their own control. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Leia and Hydroactive Surgical Dressing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 71 years |
| Region of Enrollment Sweden | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Absorption of Wound Exudates.
Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT
Time frame: 2-3 weeks
Population: Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leia | Absorption of Wound Exudates. | Poor | 0 Total no. assess. in each wounddressing |
| Leia | Absorption of Wound Exudates. | Excellent | 0 Total no. assess. in each wounddressing |
| Leia | Absorption of Wound Exudates. | Very good | 5 Total no. assess. in each wounddressing |
| Leia | Absorption of Wound Exudates. | NA | 7 Total no. assess. in each wounddressing |
| Leia | Absorption of Wound Exudates. | Good | 8 Total no. assess. in each wounddressing |
| Hydroactivate Surgical Dressing | Absorption of Wound Exudates. | NA | 8 Total no. assess. in each wounddressing |
| Hydroactivate Surgical Dressing | Absorption of Wound Exudates. | Poor | 0 Total no. assess. in each wounddressing |
| Hydroactivate Surgical Dressing | Absorption of Wound Exudates. | Good | 7 Total no. assess. in each wounddressing |
| Hydroactivate Surgical Dressing | Absorption of Wound Exudates. | Very good | 5 Total no. assess. in each wounddressing |
| Hydroactivate Surgical Dressing | Absorption of Wound Exudates. | Excellent | 1 Total no. assess. in each wounddressing |