Clinical trial NCT03877484: Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
Official title: A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Keywords: chronic and acute wounds
full-thickness
partial thickness
shadow granulating
exuding wounds
including pressure ulcers
leg ulcers
diabetic foot ulcers
dehisced surgical wounds
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty adult subjects with moderate to highly exuding wounds that require a dressing will be recruited. Only subjects with acute wounds or chronic wounds which are present \> 6 weeks will be enrolled. Chronic wounds will include pressure ulcers, leg ulcers, diabetic foot ulcers. Acute wounds will include dehisced surgical or traumatic wounds. In order to ensure a balanced distribution on chronic and acute indications, at least 10 subjects with chronic wounds and at least 10 subjects with acute wounds will be enrolled.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Wound Area From Baseline to End of Study Visit
timeFrame: Baseline through 28 days (±3 days).
Secondary outcomes:
measure: Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
timeFrame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)
measure: Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
timeFrame: Baseline, 7 days, 14 days, 21 days, 28 days
measure: Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
timeFrame: Baseline, 7 days, 14 days, 21 days, and 28 days
measure: Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
timeFrame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)
measure: Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
timeFrame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)
measure: Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
timeFrame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)
measure: Exudate Management: Number of Dressings With Leakage
timeFrame: Dressing application to removal, up to 7 days (±3 Days)
measure: Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)
measure: Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)
measure: Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
timeFrame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Reason for Dressing Change
timeFrame: Upon dressing removal, up to 7 days (±3 Days)
measure: Condition of Surrounding Skin
timeFrame: Baseline and 28 days (±3 Days)
measure: Signs of Clinical Infection
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Healing of Reference Wound
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Average Dressing Wear Time
timeFrame: Following dressing application, up to 7 days (±3 Days)
measure: Overall Level of Pain on Dressing Application
timeFrame: Immediately after dressing application
measure: Overall Level of Pain During Treatment
timeFrame: During treatment (following each dressing application prior to removal), up to 7 days (±3 Days)
measure: Overall Level Pain on Dressing Removal
timeFrame: Immediately upon dressing removal
measure: 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)
timeFrame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)
measure: 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)
timeFrame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Dressing Adherence (Retention)
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Bunching Up of Dressing
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
measure: Overall Percent of Dressing Lift
timeFrame: Dressing application to removal, up to 7 days (±3 Days)
measure: Dressing Comfort During Wear
timeFrame: 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days)
measure: Patient Assessment Scale: Leakage
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Moisture
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Odour
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Exudate
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Protection
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Comfort
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
measure: Patient Assessment Scale: Showering
timeFrame: Baseline through end of treatment, up to 28 days (±3 days)
Other outcomes:
Locations:
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier William Morey
city: Bonn
country: Germany
facility: MVZ Dermatologisches Zentrum Bonn GmbH
city: Erlangen
country: Germany
facility: University Hospital Erlangen, Department of Dermatology
city: Melle
country: Germany
facility: Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg, University Clinic for Dermatology and Allergy
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: Northumberland
Study officials:
affiliation: VZ Dermatologisches Zentrum Bonn
name: Uwe Reinhold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Erlangen, Department of Dermatology
name: Cornelia Erfurt-Berge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie
name: Ulrike Raap, MD
role: PRINCIPAL_INVESTIGATOR
References: