Evaluation Of An Advanced Borderless Dressing

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-06-18

Brief Summary

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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.

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Detailed Description

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The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU \[arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy\], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.

Conditions

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Pressure Ulcer Leg Ulcer Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ALLEVYN Life Non-Bordered

Foam Dressing

Group Type EXPERIMENTAL

ALLEVYN Life Non-Bordered

Intervention Type DEVICE

Foam Dressing

Standard care

Standard care dressing

Group Type OTHER

Standard Care

Intervention Type DEVICE

Foam Dressing

Interventions

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ALLEVYN Life Non-Bordered

Foam Dressing

Intervention Type DEVICE

Standard Care

Foam Dressing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject must provide informed consent to participate in the study.
2. The subject must be eighteen (18) years of age or older.
3. The subject must be willing and able to make all required study visits.
4. The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
5. The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:

1. 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)
2. The ulcer is, in the opinion of the Investigator, moderate to highly exuding.
3. The ulcer would, in the opinion of the Investigator, benefit from a protective dressing.
4. The ulcer is not infected based on clinical signs/symptoms.
6. 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

1. Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components.
2. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
3. The subject's reference ulcer is being treated with a topical antimicrobial dressing.
4. 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.
5. Subjects who have participated previously in this clinical trial.
6. Subjects with a history of poor compliance with medical treatment.
7. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No