N/A
Completed N=40
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
Source: ClinicalTrials.gov NCT03877484 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Dec 2024
Primary outcomePrimary: Change in Wound Area From Baseline to End of Study Visit — 2.2 square centimeters (cm^2)
Summary
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wound Area From Baseline to End of Study Visit |
2.2 | — |
| SECONDARY Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) |
0.5; 1.2; 1.7 | — |
| SECONDARY Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) |
0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) |
0.07; 0.08; 0.1; 0.1 | — |
| SECONDARY Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) |
9.5; 21.3; 40.8; 49.9 | — |
| SECONDARY Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) |
29.1; 34.7; 40; 27.7 | — |
| SECONDARY Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) |
38.7; 21.3; 40.8; 49.9 | — |
| SECONDARY Exudate Management: Number of Dressings With Leakage |
34; 208 | — |
| SECONDARY Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) |
5; 4; 13; 16; 2; 7 | — |
| SECONDARY Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days) |
5; 1; 20; 11; 3; 7 | — |
| SECONDARY Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) |
34; 5; 0; 1; 34; 6 | — |
| SECONDARY Reason for Dressing Change |
34; 72; 195; 27; 195; 27 | — |
| SECONDARY Condition of Surrounding Skin |
22; 14; 0; 0; 4; 0 | — |
| SECONDARY Signs of Clinical Infection |
2; 37; 2; 34; 1; 31 | — |
| SECONDARY Healing of Reference Wound |
0; 40; 1; 35; 1; 31 | — |
| SECONDARY Average Dressing Wear Time |
4.3 | — |
| SECONDARY Overall Level of Pain on Dressing Application |
1.1 | — |
| SECONDARY Overall Level of Pain During Treatment |
1.9 | — |
| SECONDARY Overall Level Pain on Dressing Removal |
1.1 | — |
| SECONDARY Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) |
6.2; 6.3; 5.9; 6.5; 6.6; 6.2 | — |
| SECONDARY Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days) |
52.6; 55.5; 60.8; 63.8; 61.4; 69.9 | — |
| SECONDARY Dressing Adherence (Retention) |
20; 12; 4; 2; 20; 14 | — |
| SECONDARY Bunching Up of Dressing |
29; 5; 2; 0; 33; 2 | — |
| SECONDARY Overall Percent of Dressing Lift |
5.8 | — |
| SECONDARY Dressing Comfort During Wear |
20; 15; 1; 1; 1; 19 | — |
| SECONDARY Patient Assessment Scale: Leakage |
8.6 | — |
| SECONDARY Patient Assessment Scale: Moisture |
8.5 | — |
| SECONDARY Patient Assessment Scale: Odour |
8.8 | — |
| SECONDARY Patient Assessment Scale: Exudate |
6.5 | — |
| SECONDARY Patient Assessment Scale: Protection |
8.7 | — |
| SECONDARY Patient Assessment Scale: Comfort |
8.9 | — |
| SECONDARY Patient Assessment Scale: Showering |
7.8 | — |
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent.
- 18 years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
- Presence of a moderately to highly exuding wound of at least 3cm2 in size.
- Presence of a chronic wound of at least 6 weeks duration at the point of enrollment; full-thickness, partial thickness or shallow granulating wounds.
Chronic wounds include:
- pressure ulcers or
- leg ulcers or
- diabetic foot ulcers
or
Presence of an acute wound at the point of enrollment; full thickness, partial thickness or shallow granulating wounds
Acute wounds include:
- dehisced surgical or
- traumatic wounds
- The patient has a wound size which can be treated with the available sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking care not to cover the entire dressing.
Exclusion Criteria
- Subjects with confirmed or suspected clinically infected reference wound.
- Reference wound undergoing treatment with compression therapy.
- Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.
- Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
- 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 (NCT03877484). 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. Informational only — not medical advice.