Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula

NCT03057132 | Terminated Results

• 1 other identifier: CLIN-PROT-ICH-US-05-274494
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (2)

• Percent of Epidermal Skin Loss at the Primary Site Assessed

  The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy). The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application.

  Baseline, 3 days

• Pain Scores at the Primary Site Assessed

  Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better.

  Baseline, 3 days

Study Arms (1)

Cavilon Advanced Skin Protectant

EXPERIMENTAL

Cavilon Advanced Skin Protectant

Device: Cavilon Advanced Skin Protectant

Interventions

Cavilon Advanced Skin Protectant DEVICE

Cavilon Advanced Skin Protectant

Cavilon Advanced Skin Protectant

Eligibility Criteria

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

You may qualify if:

• Is the subject 18 years of age or older?
• Does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula?
• Is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication?
• Is the subject willing to release rights to 3M for the use of the photos?
• Is there a reasonable expectation that the subject will be in the hospital or available for follow-up visits during the 14 day study period?
• Has the subject signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?

You may not qualify if:

• If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
• Does the subject have a known allergy to acrylates or cyanoacrylates?
• Does the subject have a preexisting skin disease on the areas affected that may make skin assessments for this study difficult?
• Does the skin area affected require treatment with a concomitant medication or product?
• Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?
• Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
• Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
• Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Eastern Regional Medical Center, Inc.

Philadelphia, Pennsylvania, 19124, United States

Location

Limitations and Caveats

Early termination due to enrollment issues.

Results Point of Contact

• Title: Joseph Rudolph, BSN, RN, CWOCN, DWC
• Organization: Cancer Treatment Centers of America

Joe.Rudolph@ctca-hope.com

(215) 537-4678

Study Officials

• Matthew Cooper, MD

  3M

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label no masking required
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 17, 2017
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 2, 2024
• Results First Posted: June 4, 2019

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)