Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

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).

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated using the last observation carried forward (LOCF).

Average dressing wear time in days following application

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: Only participants enrolled in the study with any Exudate Levels present (i.e., scant, small, moderate, or large) that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. Of the 40 participants enrolled, 34 participants had exudate present.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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.

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

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.

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)

Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.