Evaluation Of An Advanced Borderless Dressing
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Skin and Soft Tissue Infections, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2018 |
| Start Date: | June 15, 2017 |
| End Date: | June 12, 2018 |
A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing
Some wounds are very slow to heal. Keeping moisture at the right level in a wound is very
important, so wounds are almost always kept covered while they are healing. There are many
different dressings that can be used to cover a wound. These dressings have different
capabilities in handling the fluid that comes out of a wound. Some dressings can only be worn
for a few days, while others may be worn up to 7 days. Dressings with short wear times may
require more visits to the doctor's office for changes, while dressings with a longer wear
time may mean fewer visits to doctor's office.
Allevyn Life Non-Bordered is a new 4 layer dressing intended to cover wounds that have
moderate to heavy fluid secretion. Allevyn Life Non-Bordered can be left on a wound for up to
7 days.
This study will evaluate subject satisfaction with the dressing when used on a wound.
important, so wounds are almost always kept covered while they are healing. There are many
different dressings that can be used to cover a wound. These dressings have different
capabilities in handling the fluid that comes out of a wound. Some dressings can only be worn
for a few days, while others may be worn up to 7 days. Dressings with short wear times may
require more visits to the doctor's office for changes, while dressings with a longer wear
time may mean fewer visits to doctor's office.
Allevyn Life Non-Bordered is a new 4 layer dressing intended to cover wounds that have
moderate to heavy fluid secretion. Allevyn Life Non-Bordered can be left on a wound for up to
7 days.
This study will evaluate subject satisfaction with the dressing when used on a wound.
INCLUSION CRITERIA
1. The subject must provide informed consent to participate in the study; see Section
9.1.
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.
We found this trial at
3
sites
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