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Completed

NCT Number: NCT03877484

Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

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.

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Key information

Conditions

Wound Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Graft vs Host Disease Immune System Diseases Leg Ulcer Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier William Morey, Chalon-sur-Saône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent.
  • 18 years of age or older.
  • Willing and able to make all required study visits.
  • Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
  • Presence of a moderately to highly exuding wound of at least 3cm2 in size.
  • 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
  • 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

  • Subjects with confirmed or suspected clinically infected reference wound.
  • Reference wound undergoing treatment with compression therapy.
  • Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.
  • Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
  • 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.
  • Subjects who have participated previously in this clinical trial.
  • Subjects with a history of poor compliance with medical treatment.
  • Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study

Treatment and study plan

ALLEVYN Gentle border

Device

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.

Primary outcomes

  1. Change in Wound Area From Baseline to End of Study Visit

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

    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.

Secondary outcomes

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

    Time frame: 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.

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

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

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

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

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

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

    Time frame: 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).

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

    Time frame: 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).

  6. Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 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 visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

  7. Exudate Management: Number of Dressings With Leakage

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

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

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

    Time frame: 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

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

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

    Count of participants with wound exudate types identified as:

    • None
    • Bloody
    • Serosanguineous
    • Serous
    • Purulent

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

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

  11. Reason for Dressing Change

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

    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

  12. Condition of Surrounding Skin

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

    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

  13. Signs of Clinical Infection

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

    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.

  14. Healing of Reference Wound

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

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

  15. Average Dressing Wear Time

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

    Average dressing wear time in days following application

  16. Overall Level of Pain on Dressing Application

    Time frame: Immediately after 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.

  17. Overall Level of Pain During Treatment

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

    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.

  18. Overall Level Pain on Dressing Removal

    Time frame: Immediately upon 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.

  19. 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)

    Time frame: 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.

  20. 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)

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

  21. Dressing Adherence (Retention)

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

    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

  22. Bunching Up of Dressing

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

    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

  23. Overall Percent of Dressing Lift

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

    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

  24. Dressing Comfort During Wear

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

    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

  25. Patient Assessment Scale: Leakage

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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.

  26. Patient Assessment Scale: Moisture

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Moisture was determined based on the response to "How have you found your experience in terms of the feeling of moisture on your skin underneath the dressing" where 0 indicated unacceptable feeling of moisture and 10 indicated no feeling of moisture on the skin.

  27. Patient Assessment Scale: Odour

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Odour was determined based on the response to "How have you found your experience in terms of odour?" where 0 indicated unacceptable level of odour and 10 indicated no odour.

  28. Patient Assessment Scale: Exudate

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Exudate was determined based on the response to "How have you found your experience in terms of visible exudate?" where 0 indicated unacceptable level of visible exudate and 10 indicated no visible exudate.

  29. Patient Assessment Scale: Protection

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Protection was determined based on the response to "How protected did the dressing make your wound feel?" where 0 indicated unacceptable level of protection and 10 indicated very protected.

  30. Patient Assessment Scale: Comfort

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Comfort was determined based on the response to "How have you found your experience in terms of dressing comfort?" where 0 indicated unacceptable level of comfort and 10 indicated very comfortable.

  31. Patient Assessment Scale: Showering

    Time frame: Baseline through end of treatment, up to 28 days (±3 days)

    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. Comfort was determined based on the response to "How have you found your experience in terms of being able to maintain a normal showering routine? (NA if patient does not have a normal showering routine)" where 0 indicated unacceptable level of impact (unable to bathe) and 10 indicated no negative impact.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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