Cutting the Solid Skin Barrier to Expose the Mucocutaneous Separation Into the Opening of the Solid Skin Barrier

Overview

About this study

The purpose of this study is to examine the current recommended method of managing mucocutaneous separations, by filling the mucocutaneous separation and covering it with the solid skin barrier (wafer) compared to a new approach of cutting the solid skin barrier to expose the mucocutaneous separation into the opening of the solid skin barrier will result in differences in healing of the mucocutaneous separation over a 4-week time frame, frequency of peristomal skin infection: fungal or bacterial, and frequency of pouching system leakage.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adults aged 18 to 90.
Living in the United States.
Having had ostomy creation surgery within the past 30 days.
Having a diagnosis of mucocutaneous separation.

Exclusion Criteria:

Patients with diagnosed or suspected pyoderma gangrenosum, current malignancy at the stoma site by medical record review.
Participants with documented dementia or evident cognitive impairment on screening interview.
Participants currently intubated as these conditions change the ability of participants to participate in their ostomy self-care.
Those who do not read or write English.
Patients younger than 18 years of age and older than 90 years of age.
Any mucocutaneous separation that includes tunneling.
Any patient having a skin sensitivity or allergy to an ostomy product that would necessitate use of a nonadhesive pouching system for treatment.
Patients with a silver allergy.
A separation with measurements too small to quantify on the study measuring guide (< 0.5 sq. cm).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/14/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Kathryn Krieg, R.N., COCN	Open for enrollment	Contact information: Kathryn Krieg R.N., COCN RSTMCSresearch@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Krieg, R.N., COCN

Open for enrollment

Contact information:

Kathryn Krieg R.N., COCN

RSTMCSresearch@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials