Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals

NCT06178289 | Enrolling By Invitation FDA Device

• 1 other identifier: ONZ-2022-0527
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment. Methodology: RESEARCH DESIGN: A randomized controlled multicentre clinical trial. DATA COLLECTION: Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will centrally assess the time to healing and other healing outcomes based on the photographs of the study area. Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions. Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization). Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded (incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer. Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed. Nursing time assessment: Time per cleansing and time per treatment application.

Conditions

Irritant Dermatitis; Stoma Site Dermatitis; Wound of Skin

Outcome Measures

Primary Outcomes (1)

• Time to complete epithelialization

  Number of days from commencement of application of study device or comparator to the study area to complete resolution of partial-thickness wound

  Day 01 - Day 21

Secondary Outcomes (5)

• Proportion of participants with complete epithelialization

  Day 07, Day 14, Day 21

• Mean change in treatment related pain

  Day 01 - Day 21

• Mean change in wound pain

  Day 01, Day 02, Day 04, Day 07

• Change in maceration surface area

  Day 07, Day 14, Day 21

• Total treatment cost

  Day 04, Day 07

Study Arms (2)

3M Cavilon Advanced Skin Protectant

EXPERIMENTAL

3M Cavilon Advanced Skin Protectant (2,7ml) is a cyanoacrylate based film and will be administered every third day for a study period of 21 days.

Device: 3M Cavilon Advanced Skin Protectant

Standard hospital wound treatment protocol

ACTIVE COMPARATOR

Usual wound treatment care provided in the hospital will be administered.

Device: Standard hospital wound treatment protocol

Interventions

3M Cavilon Advanced Skin Protectant DEVICE

3M Cavilon Advanced Skin Protectant is applied to the study area of partial-thickness wounds (IAD category 2A, peri-wound MASD, peri-stomal MASD). Application of the study device should be according to the manufacturer's IFU. Comprehensive training for nurses will be provided to the study nurses.

Also known as: cyanoacrylate based film

3M Cavilon Advanced Skin Protectant

Standard hospital wound treatment protocol DEVICE

Comparator: Standard hospital wound treatment protocol

Standard hospital wound treatment protocol

Eligibility Criteria

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

You may qualify if:

• The patient or their legally authorized representative signed informed consent.
• The patient is expected to be in the study for the full duration of the trial.
• The patient has partial thickness wounds caused by moisture (MASD) i.e.,
• The patient has IAD category 2A or
• Peri-wound MASD or
• Peri-stomal MASD.

You may not qualify if:

• Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
• The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
• Intertriginous dermatitis (most often a fungal infection is present).
• Peri-fistula MASD (would usually require hospitalization).
• The patient has any other local dermatological disease or skin condition interfering with this study.
• Patients participating in another study with a known or implied effect on skin barrier function.
• Patients who are receiving end-of-life care.

Sponsors & Collaborators

• University Ghent: lead
• 3M: collaborator

Study Sites (3)

Ziekenhuis Aan de Stroom (ZAS)

Antwerp, 2030, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

AZ Oudenaarde

Oudenaarde, Belgium

Location

Related Publications (3)

• Woo KY, Beeckman D, Chakravarthy D. Management of Moisture-Associated Skin Damage: A Scoping Review. Adv Skin Wound Care. 2017 Nov;30(11):494-501. doi: 10.1097/01.ASW.0000525627.54569.da.

  PMID: 29049257 BACKGROUND

• Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.

  PMID: 21490547 BACKGROUND

• Beeckman D, Van den Bussche K, Alves P, Arnold Long MC, Beele H, Ciprandi G, Coyer F, de Groot T, De Meyer D, Deschepper E, Dunk AM, Fourie A, Garcia-Molina P, Gray M, Iblasi A, Jelnes R, Johansen E, Karadag A, Leblanc K, Kis Dadara Z, Meaume S, Pokorna A, Romanelli M, Ruppert S, Schoonhoven L, Smet S, Smith C, Steininger A, Stockmayr M, Van Damme N, Voegeli D, Van Hecke A, Verhaeghe S, Woo K, Kottner J. Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries. Br J Dermatol. 2018 Jun;178(6):1331-1340. doi: 10.1111/bjd.16327. Epub 2018 Apr 19.

  PMID: 29315488 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Irritant

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Dimitri Beeckman, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single: Investigator (central assessor of the photographs) will be blinded. The participants and care providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 20, 2023
• Study Start: January 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)