N/A
N=40
Evaluation Of An Advanced Borderless Dressing
Pressure Ulcer · Leg Ulcer · Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03146845 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
May 2023
Primary outcome: Primary: Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit — 54.3; 54.0; 71.2; 56.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ALLEVYN Life Non-Bordered (Device); Standard Care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit |
54.3; 54.0; 71.2; 56.3; 15.3; 2.3 | — |
| SECONDARY Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks |
6.0; 5.4; 17.3; 16.6; 9.5; 13.2 | — |
| SECONDARY Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score |
19.8; 20; 18.5; 19.4; 17.3; 17.0 | — |
| SECONDARY Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
0; 0; 0; 1; 12; 7 | — |
| SECONDARY Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
19; 11; 4; 2; 2; 0 | — |
| SECONDARY Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
19; 10; 3; 0; 3; 1 | — |
| SECONDARY Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
19; 10; 4; 1; 1; 1 | — |
| SECONDARY Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
22; 12; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
0; 0; 10; 6; 8; 2 | — |
| SECONDARY Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results |
0; 0; 6; 4; 1; 0 | — |
| SECONDARY Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition |
22; 11; 0; 0; 0; 1 | — |
| SECONDARY Ulcer Progression Assessed by Change From Baseline in Wound Area |
8.9; 8.7; 9.9; 4.9; -0.6; 2.2 | — |
| SECONDARY Ulcer Progression Assessed by Change From Baseline in Wound Volume |
2.7; 2.1; 2.5; 1.0; 0.3; 1.0 | — |
| SECONDARY Ulcer Progression Assessed by Change From Baseline in Wound Depth |
2.8; 3.8; 1.8; 2.7; 1.0; 1.2 | — |
| SECONDARY Number of Participants With Reference Wound Healed |
23; 11; 1; 0; 22; 10 | — |
| SECONDARY Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used |
10.4; 18.3 | — |
| SECONDARY Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change |
1.0; 1.0; 1.0; 1.9 | — |
| SECONDARY Healthcare Resource Use - Number and Type of Compression Dressings Used |
16; 7; 15; 8; 0; 0 | — |
| SECONDARY Healthcare Resource Use - Number of Participants Requiring Hospital Admission |
0; 1 | — |
| SECONDARY Healthcare Resource Use - Number of Days Participants Required In-Hospital Care |
7 | — |
| SECONDARY Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement |
33; 11; 0; 0; 69; 26 | — |
Summary
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
Eligibility Criteria
INCLUSION CRITERIA
- The subject must provide informed consent to participate in the study.
- The subject must be eighteen (18) years of age or older.
- The subject must be willing and able to make all required study visits.
- The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
- The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:
- The ulcer is classified as either:
- a pressure ulcer
- a non-ischemic diabetic foot ulcer
- a leg ulcer (arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy)
- The ulcer is, in the opinion of the Investigator, moderate to highly exuding.
- The ulcer would, in the opinion of the Investigator, benefit from a protective dressing.
- The ulcer is not infected based on clinical signs/symptoms.
- A subject with a DFU must have an ankle-brachial index (ABI) of 0.7 or greater, as measured within 30 days of the Screening Visit.
EXCLUSION CRITERIA
- Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components.
- Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
- The subject's reference ulcer is being treated with a topical antimicrobial dressing.
- Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- Subjects who have participated previously in this clinical trial.
- Subjects with a history of poor compliance with medical treatment.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Data sourced from ClinicalTrials.gov (NCT03146845). 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.