To address the hypothesis that a potato derived protease inhibitor cream significantly limits perianal dermatitis in patients after colorectal surgery.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of perianal dermatitis using the IAD score and recording with
digital day light photographs at week 2 and week 4
Secondary outcome
Patients well-being (IT-QOL)
Stooling pattern as recorded in the diary
Background summary
Perianal dermatitis can be a persistent problem in patients after colorectal
surgery. This dermatitis is very painful and difficult to treat, and as such is
a major unmet medical need.
Study objective
To address the hypothesis that a potato derived protease inhibitor cream
significantly limits perianal dermatitis in patients after colorectal surgery.
Study design
Open label observational pilot study
Study burden and risks
Risk for allergie therefore patients with known allergies are excluded
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Infant
Colorectal surgery
Perianal Dermatitis resistant to current therapy
No allergies noted
Exclusion criteria
Not speaking Dutch or understanding the study design
Known medical allergies
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-003553-17-NL |
| CCMO | NL53859.078.15 |