Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Smith & Nephew Orthopaedics AG43 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wound

Interventions

ALLEVYN Gentle borderDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Centre Hospitalier William Morey

Chalon-sur-Saône, France

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, Germany

University Hospital Erlangen, Department of Dermatology

Erlangen, Germany

Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH

Melle, Germany

Outcomes

Primary Outcomes

Change in Wound Area From Baseline to End of Study Visit

Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Time frame: Baseline through 28 days (±3 days).

Secondary Outcomes

Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)

Change in wound area from baseline to 7 days, 14 days and 21 days. Wound area was measured by photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Time frame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)

Wound depth at baseline, 7, 14, 21 and 28 days were measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Time frame: Baseline, 7 days, 14 days, 21 days, 28 days

Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)

Change in exudate wound volume measured from baseline to 7 days, 14 days, 21 days and 28 days.

Time frame: Baseline, 7 days, 14 days, 21 days, and 28 days

Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)

Percentage change in wound area from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Time frame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Data from ClinicalTrials.gov

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Klinikum Oldenburg, University Clinic for Dermatology and Allergy

Oldenburg, Germany

Northumbria Healthcare NHS Foundation Trust

Ashington, Northumberland, United Kingdom

Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)

Percentage change in wound depth from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Time frame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)

Percentage change in wound volume from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Time frame: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Exudate Management: Number of Dressings With Leakage

The count of dressings applied on participants with exudate present that experienced any dressing leakage (Yes/No).

Time frame: Dressing application to removal, up to 7 days (±3 Days)

Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)

Count of participants with wound exudate amounts identified as: * None * Scant * Small * Moderate * Large

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)

Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)

Count of participants with wound exudate types identified as: * None * Bloody * Serosanguineous * Serous * Purulent

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)

Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)

Count of participants level of odour at baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days), and 28 Days (±3 Days) identified as: * None * Mild * Moderate * Strong

Time frame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Reason for Dressing Change

Overall frequency of dressing changes categorized with the following reasons(Yes/No): * Reason for dressing change routine * ALLEVYN been in place 7 days * Dressing saturated * Strikethrough * Leakage * Pain * Dressing fell off * Dressing got wet during shower/bathing * Subject removed dressing * Other

Time frame: Upon dressing removal, up to 7 days (±3 Days)

Condition of Surrounding Skin

The condition of surrounding skin (i.e., peri-wound) was assessed to ensure there was no compromise to skin condition as a result of dressing wear, which could impact the wound healing progress. Number of participants condition of the peri-wound was classified as: * Normal * Erythematous * 50% to \<75% wound covered * 25% to \<50% wound covered * \<25% wound covered * Missing

Time frame: Baseline and 28 days (±3 Days)

Signs of Clinical Infection

Any signs of clinical infection (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits.

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Healing of Reference Wound

Wound healed (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 day (±3 Days) visits.

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Average Dressing Wear Time

Average dressing wear time in days following application

Time frame: Following dressing application, up to 7 days (±3 Days)

Overall Level of Pain on Dressing Application

Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain upon each dressing application at each scheduled study visit (7 days, 14 days, 21 days) or at any routine dressing change visit occurring between the scheduled visits.

Time frame: Immediately after dressing application

Overall Level of Pain During Treatment

Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain during treatment after each dressing application at each scheduled study visit (7 days \[ ±3 days\], 14 days \[ ±3 days\], 21 days \[ ±3 days\]) or at any routine dressing change visit occurring between the scheduled visits.

Time frame: During treatment (following each dressing application prior to removal), up to 7 days (±3 Days)

Overall Level Pain on Dressing Removal

Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain on dressing removal for each dressing applied at each scheduled study visit (7 days \[ ±3 days\], 14 days \[ ±3 days\], 21 days \[ ±3 days\]) or at any routine dressing change visit occurring between the scheduled visits.

Time frame: Immediately upon dressing removal

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)

The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Participants scored on a scale of 0 to 10 their perceived quality of life and satisfaction with quality of life. Higher scores indicate a better outcome.

Time frame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)

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)

The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Scores were on a scale from 0 to 100 with a higher score indicating a better outcome across three domains that included: * Wellbeing * Physical Symptoms \& Daily Living * Social Life

Time frame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Dressing Adherence (Retention)

The investigator determined retention by dressing adherence to the wound at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. Dressing adherence reported as the number of participants for each response to the question "Dressing still fully adhered?" from one of the following options: * Yes * Yes, but with the aid of tape or other material * No, study dressing partially adhered * No, study dressing not adhered

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Bunching Up of Dressing

The investigator determined any "bunching up" (i.e., bunching/overlap) of the dressing on the wound at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 day visits (±3 Days). Bunching of the dressing reported as the number of participants for each response to "Whether there is any bunching/overlap of dressing" from one of the following options: * None * Very Little * Moderate * Excessive

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Overall Percent of Dressing Lift

Overall percentage of dressing lift for each dressing application was determined from investigator responses following dressing removal at scheduled or routine dressing change visits to the question "Is the study dressing still fully adhered?" The following imputations were used when : * If the Investigator answered "Yes" then percentage lift was 0% * If the Investigator answered "Study dressing not adhered" then the percentage lift was 100% * If "Partially adhered" was selected, then the percentage lift was the percentage indicated in data

Time frame: Dressing application to removal, up to 7 days (±3 Days)

Dressing Comfort During Wear

Dressing comfort at 7 days (±3 Days) , 14 days (±3 Days), 21 days (±3 Days) and 28 day (±3 Days) visits determined by the number of participants with responses to "Dressing comfortable to wear since last visit" from one of the following options: * Very comfortable * Comfortable * Neither comfortable nor uncomfortable * Uncomfortable * Very uncomfortable

Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days)

Patient Assessment Scale: Leakage

Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Leakage was determined based on the response to "How have you found your experience in terms of leakage?" where 0 indicated unacceptable level of leakage and 10 indicated no leakage.