- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877484
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
December 13, 2021 updated by: Smith & Nephew Orthopaedics AG
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
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chalon-sur-Saône, France, 71321
- Centre Hospitalier William Morey
-
-
-
-
-
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
-
-
-
-
Northumberland
-
Ashington, Northumberland, United Kingdom, NE63 0HP
- Northumbria Healthcare NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical performance as measured by change in size of the wound area (cm2) over 4 weeks
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change in wound area from baseline to days 7, 14 and 21
Time Frame: up to 21 days
|
up to 21 days
|
|
Absolute change in wound depth (mm) from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
|
up to 28 days
|
|
Percentage change in wound area from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
|
up to 28 days
|
|
Frequency of wound dressing performance measures at days 7, 14, 21 and 28
Time Frame: up to 28 days
|
Description: Clinical and Dressing performance endpoints include: exudate type, amount and viscosity, odour control, dressing change frequency, condition of surrounding skin, signs of clinical infection, healing of reference wound, dressing wear time, dressing retention, presence of bunching up, percentage dressing lift, comfort during wear, showerproof qualities and pain on application, during treatment and on dressing removal.
|
up to 28 days
|
Change from baseline in subject reported outcomes using the Cardiff Wound Impact Schedule
Time Frame: 28 days
|
28 days
|
|
Number of patients with Adverse Events and Device Deficiencies
Time Frame: 28 days
|
28 days
|
|
Absolute change in wound volume (cm3) from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
|
up to 28 days
|
|
Percentage change in wound depth from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
|
up to 28 days
|
|
Percentage change in wound volume from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
|
up to 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 14, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ALLEV.PMCF.2017.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wound
-
Brigham and Women's HospitalCompletedSurgical Wound | Wound Heal | Wound of Skin | Wound OpenUnited States
-
ConvaTec Inc.Not yet recruitingSurgical Wound, Recent | Trauma-related Wound | Dehiscence Wound | Surgical Wound LeakUnited States
-
Massachusetts General HospitalCompletedWound Healing | Traumatic Wound | Infective Wound | Iatrogenic Critical Sized Wound DefectsUnited States
-
Pulmatrix Inc.TerminatedPost Operative Wound Infection | Postoperative Wound Infection-deepUnited States
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue ConditionsItaly
-
khalid abd aziz mohamedArmed Forces Hospitals, Southern Region, Saudi ArabiaUnknownDecreasing Wound InfectionSaudi Arabia
-
St. Borbala HospitalSemmelweis University; Department of Surgery, Jahn Ferend Dél-Pesti Kórház... and other collaboratorsTerminatedSurgical Wound | Surgical Site Infection | Wound Dehiscence, Surgical | Dehiscence of Internal Surgical WoundHungary
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingWound Healing | Palate; WoundBrazil
-
Central Finland Hospital DistrictUniversity of Eastern Finland; Tampere University HospitalActive, not recruitingWound Heal | Wound | Skin Wound | Skin Scarring | Wound of Skin | Wound Open | Wound BreakdownFinland
-
Chulalongkorn UniversityUnknownWound Heal | Wound Surgical | Donor Site ComplicationThailand
Clinical Trials on ALLEVYN Gentle border
-
Charite University, Berlin, GermanyCompletedPressure Ulcer PreventionGermany
-
B. Braun Medical SAUniversidad Rey Juan Carlos; Instituto de Investigación Sanitaria Gregorio...CompletedRespiratory FailureSpain
-
Smith & Nephew, Inc.WithdrawnWounds and InjuriesUnited States
-
Centre Integre Universitaire de Sante et Services...Medline IndustriesUnknownSpinal Cord InjuriesCanada
-
Melbourne HealthCompleted
-
Molnlycke Health Care ABCompleted
-
PD Dr. Jan KottnerCompletedPressure UlcerGermany
-
Molnlycke Health Care ABCompletedPressure Incidence PreventionUnited States
-
Smith & Nephew, Inc.CompletedLeg Ulcer | Diabetic Foot Ulcer | Pressure UlcerUnited States
-
Smith & Nephew, Inc.CompletedChronic WoundsUnited Kingdom