N/A
N=5
Wound Dressing With Moisture Sensor
Ulcer, Leg · Heal Wound
Bottom Line
View on ClinicalTrials.gov: NCT03468816 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Dressing Changes With Sensor Activation at Correct Timing — 0; 0; 4; 2 Dressing changes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sensor activation (on DryMax Extra Soft) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vårdcentralen Åby
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dressing Changes With Sensor Activation at Correct Timing |
0; 0; 4; 2; 3; 6 | — |
| PRIMARY Timing of Dressing Change Related to Dressing Size and Weight After Use |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Complications if the Dressing Was Switched Too Late. |
3; 2; 4; 6; 0; 0 | — |
| SECONDARY Level of Usability |
7; 8; 0; 0 | — |
| SECONDARY Wound Size After Three Dressing Changes |
127; 44 | — |
Summary
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.
Eligibility Criteria
Inclusion Criteria
- Presence of moderate to highly exuding leg ulcer by clinician assessment
- Wound deemed suitable for treatment with study product
- Informed consent from the participants.
Exclusion Criteria
- Pregnancy
- Prisoner
- Bleeding from the wound
- Known allergy to components
- Wound infection
- Mental illness
- Illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study and/or the dressing.
Data sourced from ClinicalTrials.gov (NCT03468816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.