Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis

NCT03298113 | Terminated Results FDA Device

• 1 other identifier: CLIN-PROT-EU-05-293312
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)

Conditions

Incontinence-associated Dermatitis

Outcome Measures

Primary Outcomes (1)

• Healing of IAD

  Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool) Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is "other pre-specified". The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.

  up to 21 days depending on length of hospitalization

Other Outcomes (15)

• Improvement of IAD Category

  Up to 21 days depending on length of hospitalization

• Re-epithelialization of Skin Loss

  up to 21 days depending on length of hospitalization

• Time to Heal IAD

  Up to 21 days depending on length of hospitalization

Study Arms (2)

Cavilon Advanced Skin Protectant

EXPERIMENTAL

Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.

Device: Cavilon Advanced Skin Protectant

IAD Hospital Standard Care

OTHER

Marketed products are applied according to the IAD hospital standard care routine.

Device: IAD Hospital Standard Care

Interventions

Cavilon Advanced Skin Protectant DEVICE

Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.

Cavilon Advanced Skin Protectant

IAD Hospital Standard Care DEVICE

Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.

IAD Hospital Standard Care

Eligibility Criteria

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

You may qualify if:

• Is the patient 18 years or older?
• Has the patient or their legally authorized representative signed the Informed Consent Form?
• Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
• Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
• Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
• Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?

You may not qualify if:

• Is the patient pregnant or breast feeding?
• Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
• Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
• Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
• Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
• Does the patient have any other local dermatological disease or skin condition interfering with this study?
• Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study?
• Does the patient participate in another study with a known or implied effect on skin barrier function?

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (3)

Universitair Ziekenhuis Gent

Ghent, East Flanders, 9000, Belgium

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

Limitations and Caveats

Early termination due to slow enrollment rate and overall short length of hospital stay leading to small numbers of subjects analyzed (n = 20 ITT). No confirmatory and comparative statements can be made about the effects (exploratory study design).

Results Point of Contact

• Title: Nancy Klinger, Clinical Manager
• Organization: 3M Healthcare Business Group

nmklinger@mmm.com

651 736

Study Officials

• Matthew M. Cooper, MD

  3M

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Central reader
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: October 2, 2017
• Study Start: November 17, 2017
• Primary Completion: July 10, 2018
• Study Completion: July 10, 2018
• Last Updated: December 2, 2024
• Results First Posted: September 24, 2019

Record last verified: 2024-11

Locations

BE (1); DE (1); GB (1)