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

Launched by UNIVERSITY GHENT · Dec 11, 2023

Keywords

ClinConnect Summary

This study is testing whether the 3M Cavilon Advanced Skin Protectant helps heal moisture-related skin damage (MASD) on partial-thickness wounds, compared with the usual wound care used in hospitals. Adults 18 and older with MASD around the skin (for example from incontinence, stoma areas, or wound leakage) who can stay in the study for up to 21 days are invited to participate. About 36 people will be enrolled at several Belgian hospitals. Participants are randomly assigned to receive either the Cavilon Protectant (applied every three days for up to 21 days) or the hospital’s usual wound care.

The main goal is to see how long it takes for the wound to fully heal. Additional measurements include the percentage of participants who are fully healed by days 7, 14, and 21; changes in pain related to treatment and to the wound; changes in the area of moist skin; and the overall cost of care. Although care providers can’t be blinded, a central, blinded reviewer will judge healing from daily photos. Participants will have daily skin checks and pain assessments, and nursing time spent on cleansing and treatment will be recorded. Results are not yet available, but the trial is actively enrolling and will report findings later.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.