WoundNCT03877484
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
An observational study of Wound, run by Smith & Nephew Orthopaedics AG at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- ALLEVYN Gentle border
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 6 Mar 2019to 19 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
MVZ Dermatologisches Zentrum Bonn GmbH
Bonn, 53111
University Hospital Erlangen, Department of Dermatology
Erlangen, 91054
Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH
Melle, 49324
Klinikum Oldenburg, University Clinic for Dermatology and Allergy
Oldenburg, 26133
United Kingdom1 site
Northumbria Healthcare NHS Foundation Trust
Ashington, Northumberland, NE63 0HP
About this study
Official title: 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.
- Conditions
- Wound
- Being tested
- ALLEVYN Gentle border
- Keywords
- chronic and acute wounds, full-thickness, partial thickness, shadow granulating, exuding wounds, including pressure ulcers, leg ulcers, diabetic foot ulcers, dehisced surgical wounds
- Medical subject headings
- Wounds and Injuries, Bronchiolitis Obliterans Syndrome, Leg Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 28 days (±3 days).
Secondary outcomes (31)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through end of treatment, up to 28 days (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start6 Mar 2019
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Reinhold, MD, Principal investigator, VZ Dermatologisches Zentrum BonnCornelia Erfurt-Berge, MD, Principal investigator, University Hospital Erlangen, Department of DermatologyUlrike Raap, MD, Principal investigator, Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877484
- Sponsor's protocol ID
- ALLEV.PMCF.2017.13
- Status last verified
- Dec 2021
- First submitted
- 6 Feb 2019
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
- ClinicalTrials.gov ID
- NCT03877484
- Acronym / sponsor ID
- ALLEV.PMCF.2017.13
- Conditions
- Wound
- Keywords
- chronic and acute wounds, full-thickness, partial thickness, shadow granulating, exuding wounds, including pressure ulcers, leg ulcers, diabetic foot ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLEVYN Gentle borderALLEVYN 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. | Device | – |
Primary outcome
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.
31 secondary outcomes
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 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
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
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 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 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)
Exudate Management: Number of Dressings With Leakage
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)
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)
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)
Time frame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Reason for Dressing Change
Time frame: Upon dressing removal, up to 7 days (±3 Days)
Condition of Surrounding Skin
Time frame: Baseline and 28 days (±3 Days)
Signs of Clinical Infection
Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Healing of Reference Wound
Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Average Dressing Wear Time
Time frame: Following dressing application, up to 7 days (±3 Days)
Overall Level of Pain on Dressing Application
Time frame: Immediately after dressing application
Overall Level of Pain During Treatment
Time frame: During treatment (following each dressing application prior to removal), up to 7 days (±3 Days)
Overall Level Pain on Dressing Removal
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)
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)
Time frame: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Dressing Adherence (Retention)
Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Bunching Up of Dressing
Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)
Overall Percent of Dressing Lift
Time frame: Dressing application to removal, up to 7 days (±3 Days)
Dressing Comfort During Wear
Time frame: 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days)
Patient Assessment Scale: Leakage
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Moisture
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Odour
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Exudate
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Protection
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Comfort
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Patient Assessment Scale: Showering
Time frame: Baseline through end of treatment, up to 28 days (±3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Reinhold, MD principal investigator
VZ Dermatologisches Zentrum Bonn
Cornelia Erfurt-Berge, MD principal investigator
University Hospital Erlangen, Department of Dermatology
Ulrike Raap, MD principal investigator
Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by Smith & Nephew Orthopaedics AG at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wound Area From Baseline to End of Study Visit (time frame: Baseline through 28 days (±3 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.