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

1. Is the subject 18 years of age or older?

2. 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?

3. Is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication?

4. Is the subject willing to release rights to 3M for the use of the photos?

5. 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?

6. Has the subject signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?

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 preexisting skin disease on the areas affected that may make skin assessments for this study difficult?

4. Does the skin area affected require treatment with a concomitant medication or product?

5. Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?

6. Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?

7. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?

8. Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?