Clinical trial NCT02570139: Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
Official title: Multi-Center, Randomized Trial Comparing the Efficacy of 3M™ Cavilon™ Advanced Barrier Film for the Treatment of Incontinence-associated Dermatitis to a Commercially Available Moisture Barrier
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incontinence Associated Dermatitis
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2015-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Detailed description: The purpose of this study is to evaluated the product performance of a new skin protectant formulated to protect damaged and denuded skin even in the presence of exposure to the most potentially damaging body fluids, such as liquid stool and gastric fluid. The product is expected to intimately adhere to damaged and denuded skin and provide better protection from further damage than commonly used products such as moisture barrier pastes, thereby making it easier for nursing staff to cleanse the skin after incontinence episodes, thus saving time and also materials.

The denuded sites on buttocks/thighs will be scored for skin loss and degree of redness. Over the course of time, with the skin protected, it should re-epithelizes. The skin improvement will be scored and the change in baseline over time monitored.

Eligibility criteria: Inclusion Criteria:

Subjects may be enrolled into this study if the answers to all these questions are yes.

1. Is the subject a full-term newborn (36 weeks or greater gestational age) or older?
2. Is the subject in a facility providing nursing care 24 hours per day?
3. Does the subject have severe Category 2 Incontinence-Associated Dermatitis (IAD) -red with skin breakdown (i.e. skin erosion and denudation or denudation of skin alone)?
4. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of photographs in potential publication?
5. Is the subject willing to release rights to 3M for the use of the photos?
6. Is there a reasonable expectation that the subject will remain in a facility for at least 7 days following enrollment in the study?
7. Has the subject, or their legally authorized representative, signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?

Exclusion Criteria:

* Subjects are excluded from participation in this study if any of the answers to these following questions is yes.

  1. If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
  2. Does the subject have a known allergy to acrylates or cyanoacrylates?
  3. Does the subject have a Stage III, IV, unstageable, suspected deep tissue injury pressure ulcer in the area where the skin is affected by incontinence?
  4. Does the subject have a preexisting skin disease on the areas affected by incontinence that may make skin assessments for this study difficult?
  5. Does the skin area affected by incontinence require treatment with a concomitant medication or product?
  6. Does the subject have an active genital herpes infection?
  7. Has the subject received antifungal powders in the area affected with IAD within 24 hours prior to enrollment?
  8. Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
  9. Is the facility unwilling to discontinue use for this subject of Dimethicone-containing wipes on the area where the skin protectant product will be applied?
  10. Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the skin protectant product will be applied?
  11. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
  12. Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?

Primary outcomes:
measure: Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
timeFrame: up to 21 days depending on length of hospitalization
Secondary outcomes:
measure: Re-epithelialization to a Category 1 or Lower
timeFrame: Up to 21 days depending on length of hospitalization
measure: Pain Scores During Incontinence Management
timeFrame: Up to 21 days depending on length of hospitalization
measure: Prevention of IAD.
timeFrame: Measured at study day 5
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospital and Clinics
state: Minnesota
city: Kearney
country: United States
facility: Good Samaritan
state: Nebraska
city: Lincoln
country: United States
facility: St. Elizabeth
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Lennox Hill
state: New York
city: Tulsa
country: United States
facility: St. John
state: Oklahoma
city: Charleston
country: United States
facility: Roper St. Francis
state: South Carolina
city: Plano
country: United States
facility: Baylor Plano
state: Texas
Study officials:
affiliation: 3M
name: Pat Parks, MD
role: STUDY_DIRECTOR
References: