Ulcer Foot, Ulcer Healing, Wound Infection
Conditions
Brief summary
Retrospective, multi-site, non-comparative, post-market study
Detailed description
Retrospective, multi-site, non-comparative, post-market study to evaluate real-world performance of Aquacel WSF Ribbon dressings in wound healing
Interventions
DEVICEAquacel Ribbon
Subjects who received an Aquacel WSF Ribbon
Sponsors
ConvaTec Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Subjects who have received one or more Aquacel WSF Ribbon dressing
Exclusion criteria
* Patients who have not received one or more Aquacel WSF Ribbon dressings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world efficacy of Aquacel WSF Ribbon in improving the incidence of wound closure | Baseline and week 4, 12, 20 | Time to complete wound closure, defined as 100% epithelialization of the wound surface |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wound dept | Baseline and week 4, 12, 20 | Measured wound depth at each visit |
| Exudate volume | Baseline and week 4, 12, 20 | Changes in exudate volume |
| Wound size | Baseline and week 4, 12, 20 | Measured size (area, volume) of target wound at each visit |
| Visit frequency | Up to week 20 | Number of visit frequency |
| Dressing wear time | Baseline and week 4, 12, 20 | Aquacel WSF Ribbon wear time |
| Application use | Up to week 20 | Number of Aquacel WSF Ribbon applications per subject over treatment course |
Outcome results
None listed