Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Completed

Conditions: Wound

Registration Number: NCT03877484

Lead Sponsor: Smith & Nephew Orthopaedics AG

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Wound Area From Baseline to End of Study Visit	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 Outcome Measures

Name	Time	Method
Patient Assessment Scale: Leakage	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.
Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)	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.
Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)	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.
Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)	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.
Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)	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).
Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)	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).
Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)	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).
Exudate Management: Number of Dressings With Leakage	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).
Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)	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
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)	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
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)	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
Reason for Dressing Change	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
Condition of Surrounding Skin	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
Signs of Clinical Infection	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.
Healing of Reference Wound	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.
Average Dressing Wear Time	Following dressing application, up to 7 days (±3 Days)	Average dressing wear time in days following application
Overall Level of Pain on Dressing Application	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.
Overall Level of Pain During Treatment	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.
Overall Level Pain on Dressing Removal	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.
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)	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.
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)	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
Dressing Adherence (Retention)	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
Bunching Up of Dressing	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
Overall Percent of Dressing Lift	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
Dressing Comfort During Wear	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
Patient Assessment Scale: Moisture	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.
Patient Assessment Scale: Odour	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.
Patient Assessment Scale: Exudate	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.
Patient Assessment Scale: Protection	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.
Patient Assessment Scale: Comfort	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.
Patient Assessment Scale: Showering	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.

Trial Locations

Locations (6): University Hospital Erlangen, Department of Dermatology
🇩🇪
Erlangen, Germany
Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH
🇩🇪
Melle, Germany
MVZ Dermatologisches Zentrum Bonn GmbH
🇩🇪
Bonn, Germany
Centre Hospitalier William Morey
🇫🇷
Chalon-sur-Saône, France
Klinikum Oldenburg, University Clinic for Dermatology and Allergy
🇩🇪
Oldenburg, Germany
Northumbria Healthcare NHS Foundation Trust
🇬🇧
Ashington, Northumberland, United Kingdom