Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Wound Clinical Trial

Official title:

A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877484
• Other study ID #: ALLEV.PMCF.2017.13
• Status: Completed
• Start date: March 6, 2019
• Est. completion date: November 19, 2021

Study information

• Verified date: December 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed written informed consent.

2. 18 years of age or older.

3. Willing and able to make all required study visits.

4. Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.

5. Presence of a moderately to highly exuding wound of at least 3cm2 in size.

6. 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

7. 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:

1. Subjects with confirmed or suspected clinically infected reference wound.

2. Reference wound undergoing treatment with compression therapy.

3. Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.

4. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.

5. 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.

6. Subjects who have participated previously in this clinical trial.

7. Subjects with a history of poor compliance with medical treatment.

8. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• ALLEVYN Gentle border
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.

Locations

Country	Name	City	State
France	Centre Hospitalier William Morey	Chalon-sur-Saône
Germany	MVZ Dermatologisches Zentrum Bonn GmbH	Bonn
Germany	University Hospital Erlangen, Department of Dermatology	Erlangen
Germany	Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH	Melle
Germany	Klinikum Oldenburg, University Clinic for Dermatology and Allergy	Oldenburg
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Ashington	Northumberland

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance as measured by change in size of the wound area (cm2) over 4 weeks		4 weeks
Secondary	Absolute change in wound area from baseline to days 7, 14 and 21		up to 21 days
Secondary	Absolute change in wound depth (mm) from baseline to days 7, 14, 21 and 28		up to 28 days
Secondary	Percentage change in wound area from baseline to days 7, 14, 21 and 28		up to 28 days
Secondary	Frequency of wound dressing performance measures at days 7, 14, 21 and 28	Description: Clinical and Dressing performance endpoints include: exudate type, amount and viscosity, odour control, dressing change frequency, condition of surrounding skin, signs of clinical infection, healing of reference wound, dressing wear time, dressing retention, presence of bunching up, percentage dressing lift, comfort during wear, showerproof qualities and pain on application, during treatment and on dressing removal.	up to 28 days
Secondary	Change from baseline in subject reported outcomes using the Cardiff Wound Impact Schedule		28 days
Secondary	Number of patients with Adverse Events and Device Deficiencies		28 days
Secondary	Absolute change in wound volume (cm3) from baseline to days 7, 14, 21 and 28		up to 28 days
Secondary	Percentage change in wound depth from baseline to days 7, 14, 21 and 28		up to 28 days
Secondary	Percentage change in wound volume from baseline to days 7, 14, 21 and 28		up to 28 days