Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate 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.

Study Overview

• Status: Completed
• Conditions: Wound
• Intervention / Treatment: Device: ALLEVYN Gentle border

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• France
  • Chalon-sur-Saône, France, 71321
    • Centre Hospitalier William Morey
• Germany
  • Bonn, Germany, 53111
    • MVZ Dermatologisches Zentrum Bonn GmbH
  • Erlangen, Germany, 91054
    • University Hospital Erlangen, Department of Dermatology
  • Melle, Germany, 49324
    • Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg, University Clinic for Dermatology and Allergy
• United Kingdom
  • Northumberland
    • Ashington, Northumberland, United Kingdom, NE63 0HP
      • Northumbria Healthcare NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 28 days (±3 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)
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).	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).	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).	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	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	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	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	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	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.	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.	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	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.	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.	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.	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.	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	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	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	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	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	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Moisture	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Odour	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Exudate	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Protection	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Comfort	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.	Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Showering	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.	Baseline through end of treatment, up to 28 days (±3 days)

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Uwe Reinhold, MD, VZ Dermatologisches Zentrum Bonn; Principal Investigator: Cornelia Erfurt-Berge, MD, University Hospital Erlangen, Department of Dermatology; Principal Investigator: Ulrike Raap, MD, Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: leg ulcers; diabetic foot ulcers; partial thickness; chronic and acute wounds; full-thickness; shadow granulating; exuding wounds; including pressure ulcers; dehisced surgical wounds
• Other Study ID Numbers: ALLEV.PMCF.2017.13