Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

NCT03877484 | Completed Results

• 1 other identifier: ALLEV.PMCF.2017.13
• Study Type: observational
• Target: 43
• Locations: 3 countries
• Sites: 6

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.

Conditions

Wound

Keywords

chronic and acute wounds; full-thickness; partial thickness; shadow granulating; exuding wounds; including pressure ulcers; leg ulcers; diabetic foot ulcers; dehisced surgical wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (31)

• 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 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

• 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

• 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 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)

Interventions

ALLEVYN Gentle border DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed written informed consent.
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (6)

Centre Hospitalier William Morey

Chalon-sur-Saône, 71321, France

Location

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, 53111, Germany

Location

University Hospital Erlangen, Department of Dermatology

Erlangen, 91054, Germany

Location

Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH

Melle, 49324, Germany

Location

Klinikum Oldenburg, University Clinic for Dermatology and Allergy

Oldenburg, 26133, Germany

Location

Northumbria Healthcare NHS Foundation Trust

Ashington, Northumberland, NE63 0HP, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Bronchiolitis Obliterans Syndrome; Leg Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

The original study protocol did not specify that participants should have a minimum wound area in the inclusion criteria. As such, several patients were enrolled with particularly small wound areas, limiting the ability to demonstrate suitable wound area reduction. Furthermore, there were eleven participants included who had low levels of exudate at baseline, which was a limiting factor in being able to demonstrate exudate management of the dressing.

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Smith and Nephew

rebecca.mcdonald@smith-nephew.com

1482673917

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: March 15, 2019
• Study Start: March 6, 2019
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2021-12

Locations

GB (1); DE (4); FR (1)